Trial Outcomes & Findings for A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder (NCT NCT00555997)
NCT ID: NCT00555997
Last Updated: 2014-07-03
Results Overview
Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
6 weeks
Results posted on
2014-07-03
Participant Flow
Participant milestones
| Measure |
Phase 1 Ziprasidone
Subjects taking ziprasidone in the first phase.
|
Phase 1 Placebo
Subjects taking placebo in the first phase.
|
Phase 2 Ziprasidone
Subjects taking ziprasidone in the second phase.
|
Phase 2 Placebo
Patients who received placebo in phase 2.
|
|---|---|---|---|---|
|
Phase 1 SPCD
STARTED
|
29
|
91
|
0
|
0
|
|
Phase 1 SPCD
COMPLETED
|
17
|
76
|
0
|
0
|
|
Phase 1 SPCD
NOT COMPLETED
|
12
|
15
|
0
|
0
|
|
Phase 2 SPCD
STARTED
|
0
|
0
|
38
|
25
|
|
Phase 2 SPCD
COMPLETED
|
0
|
0
|
31
|
22
|
|
Phase 2 SPCD
NOT COMPLETED
|
0
|
0
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo/Ziprasidone
n=47 Participants
Received placebo in first phase and ziprasidone in second phase
|
Placebo
n=44 Participants
Subjects received placebo throughout study
|
Ziprasidone
n=29 Participants
Subjects received ziprasidone throughout study
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
44.6 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
41.5 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
43.7 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
44 participants
n=107 Participants
|
29 participants
n=206 Participants
|
120 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 weeksHigher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Outcome measures
| Measure |
Phase 1 Ziprasidone
n=29 Participants
Subjects taking ziprasidone in the first phase.
|
Phase 1 Placebo
n=91 Participants
Subjects taking placebo in the first phase.
|
Phase 2 Ziprasidone
n=21 Participants
Subjects taking ziprasidone in the second phase.
|
Phase 2 Placebo
n=25 Participants
Patients who received placebo in phase 2.
|
|---|---|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D-17) Scores
Mean phase baseline score
|
20.1 points
Standard Deviation 5.5
|
19.9 points
Standard Deviation 4.8
|
14.7 points
Standard Deviation 3.9
|
15.6 points
Standard Deviation 5.9
|
|
Hamilton Depression Rating Scale (HAM-D-17) Scores
Mean phase score reduction
|
-8.8 points
Standard Deviation 7.3
|
-7.1 points
Standard Deviation 7.0
|
-2.1 points
Standard Deviation 5.2
|
-4.3 points
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 6 weeksA responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).
Outcome measures
| Measure |
Phase 1 Ziprasidone
n=29 Participants
Subjects taking ziprasidone in the first phase.
|
Phase 1 Placebo
n=91 Participants
Subjects taking placebo in the first phase.
|
Phase 2 Ziprasidone
n=21 Participants
Subjects taking ziprasidone in the second phase.
|
Phase 2 Placebo
n=25 Participants
Patients who received placebo in phase 2.
|
|---|---|---|---|---|
|
Responder/Non-responder
|
44.8 percentage of patients
|
31.8 percentage of patients
|
23.8 percentage of patients
|
28.0 percentage of patients
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Forms not analyzable due to insufficient standardization across sites.
Outcome measures
Outcome data not reported
Adverse Events
Ziprasidone
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziprasidone
n=125 participants at risk；n=80 participants at risk
Adverse events experienced by subjects while taking ziprasidone
|
Placebo
n=80 participants at risk；n=125 participants at risk
Adverse events experienced when taking placebo
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to suicidal ideation
|
0.00%
0/80 • 1 year, 4 months
|
0.80%
1/125 • Number of events 1 • 1 year, 4 months
|
Other adverse events
| Measure |
Ziprasidone
n=125 participants at risk；n=80 participants at risk
Adverse events experienced by subjects while taking ziprasidone
|
Placebo
n=80 participants at risk；n=125 participants at risk
Adverse events experienced when taking placebo
|
|---|---|---|
|
Psychiatric disorders
Sedation/Fatigue
|
10.4%
13/125 • 1 year, 4 months
|
3.8%
3/80 • 1 year, 4 months
|
|
Nervous system disorders
Headache
|
2.4%
3/125 • 1 year, 4 months
|
2.5%
2/80 • 1 year, 4 months
|
|
Psychiatric disorders
Insomnia
|
1.6%
2/125 • 1 year, 4 months
|
3.8%
3/80 • 1 year, 4 months
|
|
Nervous system disorders
Dizziness
|
1.6%
2/125 • 1 year, 4 months
|
2.5%
2/80 • 1 year, 4 months
|
|
Nervous system disorders
Blurry/Double Vision
|
1.6%
2/125 • 1 year, 4 months
|
2.5%
2/80 • 1 year, 4 months
|
|
Psychiatric disorders
Akathisia/Agitation
|
0.80%
1/125 • 1 year, 4 months
|
1.2%
1/80 • 1 year, 4 months
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
6/125 • 1 year, 4 months
|
7.5%
6/80 • 1 year, 4 months
|
|
Gastrointestinal disorders
Constipation
|
2.4%
3/125 • 1 year, 4 months
|
3.8%
3/80 • 1 year, 4 months
|
|
Gastrointestinal disorders
Increased appetite
|
2.4%
3/125 • 1 year, 4 months
|
0.00%
0/80 • 1 year, 4 months
|
|
Gastrointestinal disorders
Nausea
|
0.80%
1/125 • 1 year, 4 months
|
2.5%
2/80 • 1 year, 4 months
|
|
Gastrointestinal disorders
Weight gain
|
0.00%
0/125 • 1 year, 4 months
|
1.2%
1/80 • 1 year, 4 months
|
|
General disorders
Sexual dysfunction
|
0.80%
1/125 • 1 year, 4 months
|
2.5%
2/80 • 1 year, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place