Trial Outcomes & Findings for Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State (NCT NCT00490542)
NCT ID: NCT00490542
Last Updated: 2016-07-29
Results Overview
Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2016-07-29
Participant Flow
Participant milestones
| Measure |
Double-blind Flexible-dose Placebo Arm
Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
|
Double-blind Flexible-dose Ziprasidone Arm
Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Double-blind Flexible-dose Placebo Arm
Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
|
Double-blind Flexible-dose Ziprasidone Arm
Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
Baseline Characteristics
Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
Baseline characteristics by cohort
| Measure |
Placebo Arm
n=38 Participants
Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
|
Geodon Arm
n=35 Participants
Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 12.7 • n=93 Participants
|
39.1 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
35 participants
n=4 Participants
|
73 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksPopulation: Power analysis, with beta=0.20 and two-tailed alpha=0.05, was based on pilot studies for the mania registration trials which included mixed episodes and assessed MADRS scores. A projected standard error of the mean difference was assumed to be about twice as much as the mean difference (5-15 points), producing a sample size of about 100.
Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.
Outcome measures
| Measure |
Ziprasidone Arm
n=35 Participants
Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
|
Placebo Arm
n=38 Participants
Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
|
|---|---|---|
|
The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.
|
11.4 Scores on a scale
Interval 7.101815 to 15.69818
|
5.9 Scores on a scale
Interval 1.954045 to 9.845955
|
Adverse Events
Placebo Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Geodon Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Arm
n=38 participants at risk
Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
|
Geodon Arm
n=35 participants at risk
Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
|
|---|---|---|
|
Psychiatric disorders
akathesia
|
2.6%
1/38 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
General disorders
chest pain
|
2.6%
1/38 • Number of events 1
|
0.00%
0/35
|
|
General disorders
sedation
|
0.00%
0/38
|
5.7%
2/35 • Number of events 2
|
|
General disorders
migraines
|
2.6%
1/38 • Number of events 1
|
0.00%
0/35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place