Trial Outcomes & Findings for Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression (NCT NCT00852202)
NCT ID: NCT00852202
Last Updated: 2018-08-23
Results Overview
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2018-08-23
Participant Flow
233 patients were randomized to receive double-blind treatment, 227 patients received at least 1 dose of double-blind treatment and were included in safety Population
Participant milestones
| Measure |
Placebo
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
77
|
75
|
75
|
|
Overall Study
COMPLETED
|
60
|
63
|
49
|
|
Overall Study
NOT COMPLETED
|
17
|
12
|
26
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
7
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
2
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
6
|
|
Overall Study
pregnancy,moving away and surgery
|
1
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Placebo
n=77 Participants
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
n=75 Participants
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
n=75 Participants
Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
37.4 Years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
38.8 Years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
38.9 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
|
Age, Customized
< 20
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Customized
20, 30
|
11 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Age, Customized
30, 40
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Age, Customized
40, 50
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Age, Customized
50, 60
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Age, Customized
≥ 60
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
46 participant
n=99 Participants
|
48 participant
n=107 Participants
|
51 participant
n=206 Participants
|
145 participant
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
31 participant
n=99 Participants
|
27 participant
n=107 Participants
|
24 participant
n=206 Participants
|
82 participant
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
214 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
54 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
172 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 54 for 1.5 to 3.0 mg Cariprazine
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
Outcome measures
| Measure |
Placebo
n=60 Participants
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
n=64 Participants
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
n=54 Participants
Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
|
29.9 Score on scale
Standard Error 0.6
|
30.2 Score on scale
Standard Error 0.6
|
30.9 Score on scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 53 for 1.5 to 3.0 mg Cariprazine
The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.
Outcome measures
| Measure |
Placebo
n=60 Participants
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
n=64 Participants
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
n=74 Participants
Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks
|
|---|---|---|---|
|
Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )
|
2.1 Score on Scale
Standard Error 0.1
|
2.1 Score on Scale
Standard Error 0.1
|
2.1 Score on Scale
Standard Error 0.2
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
0.25 to 0.75 mg Cariprazine
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
1.5 to 3.0 mg Cariprazine
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=77 participants at risk
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
n=75 participants at risk
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
n=75 participants at risk
1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
|
|---|---|---|---|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/77
|
0.00%
0/75
|
1.3%
1/75
|
|
Psychiatric disorders
Suicidal ideation
|
1.3%
1/77
|
0.00%
0/75
|
1.3%
1/75
|
|
Psychiatric disorders
Suicidal attempt
|
0.00%
0/77
|
1.3%
1/75
|
0.00%
0/75
|
|
Psychiatric disorders
Bipolar disorder
|
1.3%
1/77
|
0.00%
0/75
|
0.00%
0/75
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/77
|
1.3%
1/75
|
0.00%
0/75
|
|
Psychiatric disorders
Depression
|
0.00%
0/77
|
0.00%
0/75
|
1.3%
1/75
|
Other adverse events
| Measure |
Placebo
n=77 participants at risk
Matching placebo capsules, orally administered for 8 weeks
|
0.25 to 0.75 mg Cariprazine
n=75 participants at risk
Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks
|
1.5 to 3.0 mg Cariprazine
n=75 participants at risk
1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
9.1%
7/77
|
17.3%
13/75
|
20.0%
15/75
|
|
Nervous system disorders
Akathisia
|
6.5%
5/77
|
2.7%
2/75
|
17.3%
13/75
|
|
Nervous system disorders
Headache
|
15.6%
12/77
|
14.7%
11/75
|
16.0%
12/75
|
|
Gastrointestinal disorders
Nausea
|
5.2%
4/77
|
12.0%
9/75
|
12.0%
9/75
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
5/77
|
9.3%
7/75
|
9.3%
7/75
|
|
General disorders
Fatigue
|
6.5%
5/77
|
9.3%
7/75
|
8.0%
6/75
|
|
Investigations
Weight Increase
|
1.3%
1/77
|
1.3%
1/75
|
8.0%
6/75
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
5/77
|
13.3%
10/75
|
6.7%
5/75
|
|
Psychiatric disorders
Anxiety
|
6.5%
5/77
|
2.7%
2/75
|
6.7%
5/75
|
|
Psychiatric disorders
Restlessness
|
3.9%
3/77
|
2.7%
2/75
|
6.7%
5/75
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77
|
1.3%
1/75
|
6.7%
5/75
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/77
|
0.00%
0/75
|
5.3%
4/75
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
4/77
|
9.3%
7/75
|
13.3%
10/75
|
|
Nervous system disorders
Migraine
|
1.3%
1/77
|
6.7%
5/75
|
0.00%
0/75
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
8/77
|
14.7%
11/75
|
10.7%
8/75
|
|
Gastrointestinal disorders
Constipation
|
6.5%
5/77
|
6.7%
5/75
|
4.0%
3/75
|
|
Gastrointestinal disorders
Flatulence
|
5.2%
4/77
|
1.3%
1/75
|
0.00%
0/75
|
|
Nervous system disorders
Dizziness
|
6.5%
5/77
|
2.7%
2/75
|
4.0%
3/75
|
|
Nervous system disorders
Dysgeusia
|
5.2%
4/77
|
1.3%
1/75
|
2.7%
2/75
|
|
Nervous system disorders
Sedation
|
6.5%
5/77
|
2.7%
2/75
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/77
|
5.3%
4/75
|
0.00%
0/75
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER