ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 33 for:    augmentation | "Depressive Disorder, Treatment-Resistant"

Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00633399
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Ziprasidone
Drug: Placebo
Enrollment 458

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Ziprasidone + Escitalopram Placebo + Escitalopram
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 71 68
Completed 49 53
Not Completed 22 15
Arm/Group Title Ziprasidone + Escitalopram Placebo + Escitalopram Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 71 68 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 68 participants 139 participants
44.7  (13.8) 44.2  (11.0) 44.5  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 68 participants 139 participants
Female
49
  69.0%
49
  72.1%
98
  70.5%
Male
22
  31.0%
19
  27.9%
41
  29.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants 68 participants 139 participants
71 68 139
1.Primary Outcome
Title The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2
Hide Description 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.
Time Frame 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ziprasidone + Escitalopram Placebo + Escitalopram
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 71 68
Measure Type: Number
Unit of Measure: Percentage of patients
35.2 20.5
2.Secondary Outcome
Title Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.
Hide Description A 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ziprasidone + Escitalopram Placebo + Escitalopram
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 71 68
Measure Type: Number
Unit of Measure: Percentage of patients
38 30
3.Secondary Outcome
Title Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8
Hide Description This 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ziprasidone + Escitalopram Placebo + Escitalopram
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.4  (6.4) -3.3  (6.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ziprasidone + Escitalpram Ziprasidone + Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Ziprasidone + Escitalpram Ziprasidone + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ziprasidone + Escitalpram Ziprasidone + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/71 (0.00%)      0/68 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ziprasidone + Escitalpram Ziprasidone + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/71 (71.83%)      42/68 (61.76%)    
Gastrointestinal disorders     
Dry Mouth   7/71 (9.86%)  7 11/68 (16.18%)  11
Nausea   3/71 (4.23%)  3 9/68 (13.24%)  9
GI Upset   8/71 (11.27%)  8 3/68 (4.41%)  3
Metabolism and nutrition disorders     
Weight Gain   1/71 (1.41%)  1 4/68 (5.88%)  4
Nervous system disorders     
Somnolence and/or Fatigue   24/71 (33.80%)  24 8/68 (11.76%)  8
Akathisia   11/71 (15.49%)  11 5/68 (7.35%)  5
Headaches   5/71 (7.04%)  5 9/68 (13.24%)  9
Irritability   7/71 (9.86%)  7 1/68 (1.47%)  1
Poor concentration and/or memory   6/71 (8.45%)  6 1/68 (1.47%)  1
Insomnia   6/71 (8.45%)  6 6/68 (8.82%)  6
Dizziness   5/71 (7.04%)  5 3/68 (4.41%)  3
Anxiety and/or Agitation   4/71 (5.63%)  4 0/68 (0.00%)  0
Muscle Twitching   8/71 (11.27%)  8 1/68 (1.47%)  1
Sexual Dysfunction   7/71 (9.86%)  7 5/68 (7.35%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: George I Papakostas, M.D. - Scientific Director
Organization: Massachusetts General Hospital CNTI
Phone: 6177266697
Responsible Party: George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00633399     History of Changes
Other Study ID Numbers: 2007-P-002361
First Submitted: March 4, 2008
First Posted: March 12, 2008
Results First Submitted: June 24, 2014
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014