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A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder (Geodon)

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ClinicalTrials.gov Identifier: NCT00555997
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Collaborators:
Cambridge Health Alliance
University of Connecticut
Vanderbilt University
Psychiatric Medicine Associates, L.L.C.
Cedars-Sinai Medical Center
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 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1 Ziprasidone Phase 1 Placebo Phase 2 Ziprasidone Phase 2 Placebo
Hide Arm/Group Description Subjects taking ziprasidone in the first phase. Subjects taking placebo in the first phase. Subjects taking ziprasidone in the second phase. Patients who received placebo in phase 2.
Period Title: Phase 1 SPCD
Started 29 91 0 0
Completed 17 76 0 0
Not Completed 12 15 0 0
Period Title: Phase 2 SPCD
Started 0 0 38 25
Completed 0 0 31 22
Not Completed 0 0 7 3
Arm/Group Title Placebo/Ziprasidone Placebo Ziprasidone Total
Hide Arm/Group Description Received placebo in first phase and ziprasidone in second phase Subjects received placebo throughout study Subjects received ziprasidone throughout study Total of all reporting groups
Overall Number of Baseline Participants 47 44 29 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 29 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
 100.0%
42
  95.5%
29
 100.0%
118
  98.3%
>=65 years
0
   0.0%
2
   4.5%
0
   0.0%
2
   1.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 44 participants 29 participants 120 participants
44.1  (11.1) 44.6  (11.0) 41.5  (10.6) 43.7  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 29 participants 120 participants
Female
18
  38.3%
22
  50.0%
13
  44.8%
53
  44.2%
Male
29
  61.7%
22
  50.0%
16
  55.2%
67
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 44 participants 29 participants 120 participants
47 44 29 120
1.Primary Outcome
Title Hamilton Depression Rating Scale (HAM-D-17) Scores
Hide Description Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ziprasidone Phase I Placebo Phase I Ziprasidone Phase II Placebo Phase II
Hide Arm/Group Description:
Results from phase I for those taking ziprasidone during that phase
Results from phase I for those taking placebo during that phase
Results from phase II for those taking ziprasidone during that phase
Results from phase II for those taking placebo during that phase
Overall Number of Participants Analyzed 29 91 21 25
Mean (Standard Deviation)
Unit of Measure: points
Mean phase baseline score 20.1  (5.5) 19.9  (4.8) 14.7  (3.9) 15.6  (5.9)
Mean phase score reduction -8.8  (7.3) -7.1  (7.0) -2.1  (5.2) -4.3  (6.0)
2.Secondary Outcome
Title Responder/Non-responder
Hide Description A 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).
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ziprasidone Phase I Placebo Phase I Ziprasidone Phase II Placebo Phase II
Hide Arm/Group Description:
Results from phase I for those taking ziprasidone during that phase
Results from phase I for those taking placebo during that phase
Results from phase II for those taking ziprasidone during that phase
Results from phase II for those taking placebo during that phase
Overall Number of Participants Analyzed 29 91 21 25
Measure Type: Number
Unit of Measure: percentage of patients
44.8 31.8 23.8 28.0
3.Secondary Outcome
Title Change in 6-VAS-D Scores During Each Phase.
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Forms not analyzable due to insufficient standardization across sites.
Arm/Group Title Phase 1 Ziprasidone Phase 1 Placebo Phase 2 Ziprasidone Phase 2 Placebo
Hide Arm/Group Description:
Subjects taking ziprasidone in the first phase.
Subjects taking placebo in the first phase.
Subjects taking ziprasidone in the second phase.
Patients who received placebo in phase 2.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year, 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description Adverse events experienced by subjects while taking ziprasidone Adverse events experienced when taking placebo
All-Cause Mortality
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ziprasidone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/80 (0.00%)      1/125 (0.80%)    
Psychiatric disorders     
Hospitalization due to suicidal ideation  0/80 (0.00%)  0 1/125 (0.80%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Ziprasidone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/125 (24.80%)      22/80 (27.50%)    
Gastrointestinal disorders     
Dry mouth  6/125 (4.80%)  6/80 (7.50%) 
Constipation  3/125 (2.40%)  3/80 (3.75%) 
Increased appetite  3/125 (2.40%)  0/80 (0.00%) 
Nausea  1/125 (0.80%)  2/80 (2.50%) 
Weight gain  0/125 (0.00%)  1/80 (1.25%) 
General disorders     
Sexual dysfunction  1/125 (0.80%)  2/80 (2.50%) 
Nervous system disorders     
Headache  3/125 (2.40%)  2/80 (2.50%) 
Dizziness  2/125 (1.60%)  2/80 (2.50%) 
Blurry/Double Vision  2/125 (1.60%)  2/80 (2.50%) 
Psychiatric disorders     
Sedation/Fatigue  13/125 (10.40%)  3/80 (3.75%) 
Insomnia  2/125 (1.60%)  3/80 (3.75%) 
Akathisia/Agitation  1/125 (0.80%)  1/80 (1.25%) 
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: Dr. George Papakostas
Organization: Massachusetts General Hospital
Phone: 617-726-6697
Responsible Party: George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00555997     History of Changes
Obsolete Identifiers: NCT00657592
Other Study ID Numbers: 2007-P-000623
First Submitted: November 7, 2007
First Posted: November 9, 2007
Results First Submitted: July 9, 2013
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014