Trial Outcomes & Findings for Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs (NCT NCT00633399)
NCT ID: NCT00633399
Last Updated: 2014-07-03
Results Overview
The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
458 participants
Primary outcome timeframe
8 Weeks
Results posted on
2014-07-03
Participant Flow
458 patients met eligibility criteria for the study and were enrolled in an 8-week, open-label, flexible dose trial of escitalopram. At the end of this open-label trial, 139 patients not responding to Escitalopram were randomized to receive adjunctive ziprasidone or adjunctive placebo.
Participant milestones
| Measure |
Ziprasidone + Escitalopram
Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
|
Placebo + Escitalopram
Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
68
|
|
Overall Study
COMPLETED
|
49
|
53
|
|
Overall Study
NOT COMPLETED
|
22
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs
Baseline characteristics by cohort
| Measure |
Ziprasidone + Escitalopram
n=71 Participants
Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
|
Placebo + Escitalopram
n=68 Participants
Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
68 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 WeeksThe primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.
Outcome measures
| Measure |
Ziprasidone + Escitalopram
n=71 Participants
Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
|
Placebo + Escitalopram
n=68 Participants
Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
|
|---|---|---|
|
The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2
|
35.2 Percentage of patients
|
20.5 Percentage of patients
|
SECONDARY outcome
Timeframe: 8 weeksA secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2.
Outcome measures
| Measure |
Ziprasidone + Escitalopram
n=71 Participants
Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
|
Placebo + Escitalopram
n=68 Participants
Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
|
|---|---|---|
|
Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.
|
38 Percentage of patients
|
30 Percentage of patients
|
SECONDARY outcome
Timeframe: 8 weeksThis will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms.
Outcome measures
| Measure |
Ziprasidone + Escitalopram
n=71 Participants
Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
|
Placebo + Escitalopram
n=68 Participants
Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
|
|---|---|---|
|
Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8
|
-6.4 units on a scale
Standard Deviation 6.4
|
-3.3 units on a scale
Standard Deviation 6.2
|
Adverse Events
Ziprasidone + Escitalpram
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Ziprasidone + Placebo
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ziprasidone + Escitalpram
n=71 participants at risk
Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.
Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
|
Ziprasidone + Placebo
n=68 participants at risk
Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2.
Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
|
|---|---|---|
|
Nervous system disorders
Somnolence and/or Fatigue
|
33.8%
24/71 • Number of events 24
|
11.8%
8/68 • Number of events 8
|
|
Nervous system disorders
Akathisia
|
15.5%
11/71 • Number of events 11
|
7.4%
5/68 • Number of events 5
|
|
Nervous system disorders
Headaches
|
7.0%
5/71 • Number of events 5
|
13.2%
9/68 • Number of events 9
|
|
Nervous system disorders
Irritability
|
9.9%
7/71 • Number of events 7
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Poor concentration and/or memory
|
8.5%
6/71 • Number of events 6
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
8.5%
6/71 • Number of events 6
|
8.8%
6/68 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
7.0%
5/71 • Number of events 5
|
4.4%
3/68 • Number of events 3
|
|
Nervous system disorders
Anxiety and/or Agitation
|
5.6%
4/71 • Number of events 4
|
0.00%
0/68
|
|
Nervous system disorders
Muscle Twitching
|
11.3%
8/71 • Number of events 8
|
1.5%
1/68 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
9.9%
7/71 • Number of events 7
|
16.2%
11/68 • Number of events 11
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • Number of events 3
|
13.2%
9/68 • Number of events 9
|
|
Gastrointestinal disorders
GI Upset
|
11.3%
8/71 • Number of events 8
|
4.4%
3/68 • Number of events 3
|
|
Nervous system disorders
Sexual Dysfunction
|
9.9%
7/71 • Number of events 7
|
7.4%
5/68 • Number of events 5
|
|
Metabolism and nutrition disorders
Weight Gain
|
1.4%
1/71 • Number of events 1
|
5.9%
4/68 • Number of events 4
|
Additional Information
George I Papakostas, M.D. - Scientific Director
Massachusetts General Hospital CNTI
Phone: 6177266697
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place