Trial Outcomes & Findings for Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression (NCT NCT00237666)
NCT ID: NCT00237666
Last Updated: 2013-06-19
Results Overview
Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
COMPLETED
PHASE4
30 participants
Week 8
2013-06-19
Participant Flow
The trial was conducted at three research centers, located in: New York, NY; Plano, TX; and Seattle, WA. Subjects were recruited over a 37 month period.
The planned and actual study population was 30 patients, 18 years of age or older, who met DSM-IV criteria for bipolar II disorder with a history of at least one hypomanic episode.
Participant milestones
| Measure |
Ziprasidone
Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=30 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
38.61 years
STANDARD_DEVIATION 13.34 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.
Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
Baseline HAM-D
|
23.1 Scores on a scale
Standard Deviation 3.49
|
|
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
Week 8 HAM-D
|
10.57 Scores on a scale
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: Week 8Population: Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.
Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
Baseline HAM-A
|
19.47 Scores on a scale
Standard Deviation 4.10
|
|
Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
Week 8 HAM-A
|
10.69 Scores on a scale
Standard Deviation 7.09
|
SECONDARY outcome
Timeframe: Week 8Population: Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.
Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
Baseline MADRS
|
28.47 Scores on a scale
Standard Deviation 4.96
|
|
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
Week 8 MADRS
|
13.21 Scores on a scale
Standard Deviation 8.99
|
SECONDARY outcome
Timeframe: Week 8Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. 18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2
|
60 percentage of subjects with CGI-I </=2
Interval 42.0 to 77.0
|
SECONDARY outcome
Timeframe: Week 8Population: Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.
Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
Baseline CGI-S
|
4.27 Score on a scale
Standard Deviation 0.42
|
|
Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
Week 8 CGI-S
|
2.33 Score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Week 8Population: Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Baseline Q-LES-Q
|
35.07 Scores on a scale
Standard Deviation 7.34
|
|
Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Week 8 Q-LES-Q
|
48.25 Scores on a scale
Standard Deviation 12.97
|
SECONDARY outcome
Timeframe: Week 8Population: Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.
Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
Ziprasidone
n=30 Participants
Ziprasidone 20-60 mg BID
|
|---|---|
|
Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
Baseline BDI
|
27.9 Scores on a scale
Standard Deviation 9.78
|
|
Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
Week 8 BDI
|
15.0 Scores on a scale
Standard Deviation 11.82
|
Adverse Events
Ziprasidone
Serious adverse events
| Measure |
Ziprasidone
n=30 participants at risk
|
|---|---|
|
Immune system disorders
White Blood Cell Count Decreased
|
3.3%
1/30 • Number of events 1 • 10 weeks
|
Other adverse events
| Measure |
Ziprasidone
n=30 participants at risk
|
|---|---|
|
General disorders
Headache
|
23.3%
7/30 • 10 weeks
|
|
General disorders
Drowsiness
|
23.3%
7/30 • 10 weeks
|
|
General disorders
Insomnia
|
20.0%
6/30 • 10 weeks
|
|
General disorders
Fatigue
|
10.0%
3/30 • 10 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
10.0%
3/30 • 10 weeks
|
|
General disorders
Dry Mouth
|
10.0%
3/30 • 10 weeks
|
Additional Information
Dr. Michael Liebowitz
The Medical Research Network, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place