Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder. (NCT NCT01197508)
NCT ID: NCT01197508
Last Updated: 2014-04-11
Results Overview
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
COMPLETED
PHASE3
696 participants
Randomization (Week 8) to end of treatment (Week 16)
2014-04-11
Participant Flow
This multicenter study was conducted in Europe, South Africa, and Latin America between 1 September 2010 and 30 January 2012.
The study had an up to 21-day screening/washout period, and an 8-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (\<50% reduction in HAMD-17 total score during the prospective open-label ADT period, a HAMD-17 total score of ≥16 and a CGI-S score ≥4).
Participant milestones
| Measure |
0.1 mg BID TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
174
|
174
|
174
|
174
|
|
Overall Study
Received Treatment
|
174
|
174
|
171
|
174
|
|
Overall Study
COMPLETED
|
151
|
144
|
125
|
158
|
|
Overall Study
NOT COMPLETED
|
23
|
30
|
49
|
16
|
Reasons for withdrawal
| Measure |
0.1 mg BID TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
15
|
4
|
|
Overall Study
Eligiblity criteria not fulfilled
|
0
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
10
|
13
|
23
|
3
|
|
Overall Study
Severe non-compliance to protocol
|
0
|
3
|
1
|
3
|
|
Overall Study
Condition under investigation worsened
|
1
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
2
|
1
|
|
Overall Study
Study-specific withdrawal criteria
|
0
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
0
|
|
Overall Study
Other
|
2
|
3
|
2
|
2
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.
Baseline characteristics by cohort
| Measure |
0.1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
Total
n=696 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 10.66 • n=99 Participants
|
45.0 years
STANDARD_DEVIATION 11.72 • n=107 Participants
|
45.6 years
STANDARD_DEVIATION 10.72 • n=206 Participants
|
45.8 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 11.21 • n=31 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
498 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
198 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
161 participants
n=99 Participants
|
156 participants
n=107 Participants
|
157 participants
n=206 Participants
|
158 participants
n=7 Participants
|
632 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
8 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
2 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
16 participants
n=206 Participants
|
13 participants
n=7 Participants
|
53 participants
n=31 Participants
|
|
Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization
|
21.49 Scores on a scale
STANDARD_DEVIATION 3.587 • n=99 Participants
|
20.98 Scores on a scale
STANDARD_DEVIATION 3.182 • n=107 Participants
|
21.50 Scores on a scale
STANDARD_DEVIATION 3.674 • n=206 Participants
|
21.26 Scores on a scale
STANDARD_DEVIATION 3.614 • n=7 Participants
|
21.30 Scores on a scale
STANDARD_DEVIATION 3.517 • n=31 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization
|
24.69 Scores on a scale
STANDARD_DEVIATION 5.086 • n=99 Participants
|
24.67 Scores on a scale
STANDARD_DEVIATION 5.389 • n=107 Participants
|
25.03 Scores on a scale
STANDARD_DEVIATION 5.137 • n=206 Participants
|
24.11 Scores on a scale
STANDARD_DEVIATION 4.992 • n=7 Participants
|
24.62 Scores on a scale
STANDARD_DEVIATION 5.152 • n=31 Participants
|
PRIMARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
|
-11.6 units on a scale
Standard Error 0.65
|
-12.2 units on a scale
Standard Error 0.66
|
-12.2 units on a scale
Standard Error 0.69
|
-12.7 units on a scale
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated. MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)
|
48.6 percentage of participants analyzed
|
51.1 percentage of participants analyzed
|
41.2 percentage of participants analyzed
|
54.0 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Week 16Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated. MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)
|
37.0 percentage of participants analyzed
|
35.1 percentage of participants analyzed
|
30.0 percentage of participants analyzed
|
39.1 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated. MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=166 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)
|
7.5 percentage of participants analyzed
|
8.1 percentage of participants analyzed
|
9.6 percentage of participants analyzed
|
9.2 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated. MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)
|
14.7 percentage of patients analyzed
|
19.3 percentage of patients analyzed
|
15.3 percentage of patients analyzed
|
23.7 percentage of patients analyzed
|
SECONDARY outcome
Timeframe: Week 12, Week 14, Week 16Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated. MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)
|
10.6 percentage of participants analyzed
|
10.5 percentage of participants analyzed
|
8.0 percentage of participants analyzed
|
12.1 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=165 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=161 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=162 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score
|
-10.07 units on a scale
Standard Error 0.597
|
-10.21 units on a scale
Standard Error 0.603
|
-9.07 units on a scale
Standard Error 0.597
|
-11.16 units on a scale
Standard Error 0.592
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)
|
-1.5 units on a scale
Standard Error 0.09
|
-1.6 units on a scale
Standard Error 0.09
|
-1.7 units on a scale
Standard Error 0.10
|
-1.7 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores \>4 indicate worsening, while scores \<4 indicate improvement.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=173 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=174 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of "Very Much Improved" or "Much Improved" From Randomization (Week 8) to End of Treatment (Week 16)
|
59.5 percentage of participants analyzed
|
62.1 percentage of participants analyzed
|
58.8 percentage of participants analyzed
|
67.8 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=166 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=161 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=161 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)
|
-8.5 units on a scale
Standard Error 0.58
|
-8.6 units on a scale
Standard Error 0.59
|
-8.1 units on a scale
Standard Error 0.58
|
-9.3 units on a scale
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to Week 9Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=167 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=162 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=164 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=168 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in MADRS Total Score From Randomization (Week 8) to Week 9
|
-3.0 units on a scale
Standard Error 0.42
|
-3.0 units on a scale
Standard Error 0.43
|
-2.6 units on a scale
Standard Error 0.42
|
-3.2 units on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to Week 10Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=166 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=157 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in MADRS Total Score From Randomization (Week 8) to Week 10
|
-4.8 units on a scale
Standard Error 0.50
|
-5.9 units on a scale
Standard Error 0.50
|
-5.0 units on a scale
Standard Error 0.51
|
-6.0 units on a scale
Standard Error 0.50
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to Week 12Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=157 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=144 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=166 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in MADRS Total Score From Randomization (Week 8) to Week 12
|
-8.1 units on a scale
Standard Error 0.55
|
-8.5 units on a scale
Standard Error 0.56
|
-7.8 units on a scale
Standard Error 0.57
|
-8.7 units on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to Week 14Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=159 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=149 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=131 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=164 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in MADRS Total Score From Randomization (Week 8) to Week 14
|
-9.5 units on a scale
Standard Error 0.59
|
-10.6 units on a scale
Standard Error 0.60
|
-9.6 units on a scale
Standard Error 0.62
|
-11.0 units on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=168 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score
|
-6.08 units on a scale
Standard Error 0.561
|
-6.34 units on a scale
Standard Error 0.569
|
-6.21 units on a scale
Standard Error 0.592
|
-7.06 units on a scale
Standard Error 0.556
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=141 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=140 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=126 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=137 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score
|
-2.0 units on a scale
Standard Error 0.21
|
-1.8 units on a scale
Standard Error 0.22
|
-1.9 units on a scale
Standard Error 0.24
|
-2.1 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=168 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score
|
-2.1 units on a scale
Standard Error 0.20
|
-2.2 units on a scale
Standard Error 0.20
|
-2.2 units on a scale
Standard Error 0.21
|
-2.4 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=168 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score
|
-2.0 units on a scale
Standard Error 0.20
|
-2.1 units on a scale
Standard Error 0.20
|
-2.0 units on a scale
Standard Error 0.21
|
-2.3 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=166 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=162 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score
|
13.08 units on a scale
Standard Error 1.388
|
13.24 units on a scale
Standard Error 1.402
|
11.84 units on a scale
Standard Error 1.409
|
14.55 units on a scale
Standard Error 1.391
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking. Higher scores are indicative of greater enjoyment or satisfaction in each domain.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=153 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=154 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=151 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=157 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15
|
0.6 units on a scale
Standard Error 0.08
|
0.7 units on a scale
Standard Error 0.08
|
0.5 units on a scale
Standard Error 0.08
|
0.7 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment. Higher scores are indicative of greater enjoyment or satisfaction in each domain.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=170 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=166 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=162 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16
|
0.7 units on a scale
Standard Error 0.08
|
0.7 units on a scale
Standard Error 0.08
|
0.6 units on a scale
Standard Error 0.08
|
0.8 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Randomization (Week 8) to end of treatment (Week 16)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.
Outcome measures
| Measure |
0.1 mg BID TC-5214
n=171 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=168 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=163 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
Placebo
n=172 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|---|---|
|
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)
EQ-5D index score
|
0.128 units on a scale
Standard Error 0.0147
|
0.139 units on a scale
Standard Error 0.0149
|
0.133 units on a scale
Standard Error 0.0155
|
0.139 units on a scale
Standard Error 0.0146
|
|
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)
EQ-5D VAS score
|
16.4 units on a scale
Standard Error 1.52
|
17.0 units on a scale
Standard Error 1.54
|
15.9 units on a scale
Standard Error 1.61
|
18.7 units on a scale
Standard Error 1.51
|
Adverse Events
Placebo
0.1 mg BID TC-5214
1 mg BID TC-5214
4 mg BID TC-5214
Serious adverse events
| Measure |
Placebo
n=174 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
|
0.1 mg BID TC-5214
n=174 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=171 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/174
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.00%
0/171
|
|
Infections and infestations
Pneumonia
|
0.00%
0/174
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.00%
0/171
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/174
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.00%
0/171
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.00%
0/174
|
0.00%
0/171
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.57%
1/174 • Number of events 1
|
0.00%
0/174
|
0.00%
0/174
|
0.00%
0/171
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.57%
1/174 • Number of events 1
|
0.00%
0/174
|
0.00%
0/174
|
0.00%
0/171
|
|
Psychiatric disorders
Depression
|
0.00%
0/174
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.00%
0/171
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/174
|
0.00%
0/174
|
0.00%
0/174
|
1.2%
2/171 • Number of events 2
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/174
|
1.1%
2/174 • Number of events 2
|
0.57%
1/174 • Number of events 1
|
0.58%
1/171 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=174 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
|
0.1 mg BID TC-5214
n=174 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
|
1 mg BID TC-5214
n=174 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
|
4 mg BID TC-5214
n=171 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
1.1%
2/174 • Number of events 2
|
3.5%
6/171 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
6.3%
11/174 • Number of events 11
|
7.5%
13/174 • Number of events 13
|
7.5%
13/174 • Number of events 14
|
19.9%
34/171 • Number of events 35
|
|
Gastrointestinal disorders
Dry Mouth
|
1.7%
3/174 • Number of events 4
|
2.9%
5/174 • Number of events 5
|
2.9%
5/174 • Number of events 5
|
10.5%
18/171 • Number of events 18
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
12/174 • Number of events 13
|
0.57%
1/174 • Number of events 1
|
1.7%
3/174 • Number of events 4
|
1.8%
3/171 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
5.2%
9/174 • Number of events 10
|
4.0%
7/174 • Number of events 8
|
3.4%
6/174 • Number of events 7
|
6.4%
11/171 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
3/174 • Number of events 3
|
0.57%
1/174 • Number of events 1
|
1.1%
2/174 • Number of events 2
|
2.9%
5/171 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.3%
4/174 • Number of events 4
|
0.57%
1/174 • Number of events 1
|
2.3%
4/174 • Number of events 5
|
2.3%
4/171 • Number of events 4
|
|
General disorders
Fatigue
|
2.3%
4/174 • Number of events 4
|
3.4%
6/174 • Number of events 6
|
5.7%
10/174 • Number of events 10
|
5.3%
9/171 • Number of events 9
|
|
Infections and infestations
Influenza
|
4.6%
8/174 • Number of events 8
|
1.1%
2/174 • Number of events 2
|
3.4%
6/174 • Number of events 6
|
2.9%
5/171 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
5/174 • Number of events 5
|
1.7%
3/174 • Number of events 4
|
0.57%
1/174 • Number of events 1
|
0.00%
0/171
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/174
|
1.1%
2/174 • Number of events 2
|
0.57%
1/174 • Number of events 2
|
2.9%
5/171 • Number of events 6
|
|
Infections and infestations
Alanine Aminotransferase Increased
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
2.3%
4/174 • Number of events 4
|
1.2%
2/171 • Number of events 3
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
2.3%
4/174 • Number of events 4
|
0.00%
0/171
|
|
Nervous system disorders
Headache
|
13.2%
23/174 • Number of events 27
|
12.6%
22/174 • Number of events 27
|
13.8%
24/174 • Number of events 41
|
9.9%
17/171 • Number of events 17
|
|
Nervous system disorders
Dizziness
|
4.0%
7/174 • Number of events 9
|
5.2%
9/174 • Number of events 9
|
7.5%
13/174 • Number of events 13
|
7.6%
13/171 • Number of events 14
|
|
Nervous system disorders
Somnolence
|
2.9%
5/174 • Number of events 5
|
2.9%
5/174 • Number of events 5
|
4.0%
7/174 • Number of events 7
|
5.3%
9/171 • Number of events 10
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.57%
1/174 • Number of events 1
|
2.3%
4/171 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
0.57%
1/174 • Number of events 1
|
3.4%
6/174 • Number of events 6
|
5.2%
9/174 • Number of events 11
|
4.1%
7/171 • Number of events 8
|
|
Psychiatric disorders
Agitation
|
2.3%
4/174 • Number of events 4
|
1.7%
3/174 • Number of events 3
|
1.7%
3/174 • Number of events 3
|
2.9%
5/171 • Number of events 5
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/174
|
0.00%
0/174
|
2.3%
4/174 • Number of events 4
|
0.58%
1/171 • Number of events 1
|
|
Psychiatric disorders
Nightmare
|
1.1%
2/174 • Number of events 2
|
2.3%
4/174 • Number of events 4
|
0.57%
1/174 • Number of events 1
|
2.3%
4/171 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.57%
1/174 • Number of events 1
|
2.9%
5/174 • Number of events 5
|
2.3%
4/174 • Number of events 4
|
4.1%
7/171 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
4/174 • Number of events 5
|
0.00%
0/174
|
0.00%
0/174
|
0.00%
0/171
|
|
Vascular disorders
Orthostatic Hypotension
|
0.57%
1/174 • Number of events 1
|
0.57%
1/174 • Number of events 1
|
0.00%
0/174
|
4.7%
8/171 • Number of events 11
|
|
Vascular disorders
Hypotension
|
0.00%
0/174
|
0.57%
1/174 • Number of events 1
|
0.00%
0/174
|
3.5%
6/171 • Number of events 6
|
|
Vascular disorders
Hypertension
|
1.1%
2/174 • Number of events 2
|
1.1%
2/174 • Number of events 3
|
1.7%
3/174 • Number of events 3
|
2.3%
4/171 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60