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

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, June 2008

Sponsors and Collaborators: Massachusetts General Hospital
Cambridge Health Alliance
University of Connecticut
Vanderbilt University
Psychiatric Medicine Associates, L.L.C.
Cedars-Sinai Medical Center
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00555997
  Purpose

This is a study on the effectiveness, tolerability and safety of oral ziprasidone as monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD will be treated with either ziprasidone or placebo for 12 weeks.

Hypothesis: There will be a statistically significant difference in the magnitude of response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be greater in the ziprasidone monotherapy group than in the placebo group.


Condition Intervention Phase
Major Depressive Disorder
Drug: Ziprasidone
Drug: Placebo
Phase II

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Ziprasidone    Ziprasidone hydrochloride    Ziprasidone mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:   A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D-17) scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder/Non-responder [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 6-VAS-D scores during the trial will be highly correlated to the change in HAM-D-17 and QIDS-SR during the trial [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   March 2008
Estimated Study Completion Date:   August 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Patients in group 1 will receive Ziprasidone for the full 12 weeks of the study.
Drug: 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.
2: Active Comparator
Patients in Group 2 will receive placebo for the first 6 weeks of the study, then will receive Ziprasidone for the last 6 weeks.
Drug: 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.
3: Placebo Comparator
Patients in Group 3 will receive placebo for the full 12 weeks of the study.
Drug: Placebo
0mg Placebo per day. "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo

Detailed Description:

Exploratory hypothesis 1: There will be a statistically significant difference in the percentage of responders in the two treatment groups; response rates will be significantly higher for the ziprasidone monotherapy compared to the placebo group.

Exploratory hypothesis 2: The change in 6-VAS-D scores during the trial will be highly correlated to the change in HAM-D-17 and QIDS-SR during the trial.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Age 18-65.
  2. Written informed consent.
  3. MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
  4. Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.

Exclusion Criteria:

  1. Pregnant women.
  2. Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
  3. Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
  4. Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
  5. Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
  6. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
  7. Patients who meet criteria for alcohol or substance dependence, active within the last month.
  8. Any bipolar disorder (current or past).
  9. Any psychotic disorder (current or past).
  10. Psychotic features in the current episode or a history of psychotic features.
  11. History of a seizure disorder.
  12. Clinical or laboratory evidence of untreated hypothyroidism.
  13. Patients requiring excluded medications (see table 1 for details).
  14. Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
  15. Any investigational psychotropic drug within the last 3 months.
  16. Patients with significant cardiac conduction problems on screening electrocardiogram such as atrial fibrillation, atrial flutter, atrio-ventricular block, prolonged or abnormal QTc interval (i.e. QTc>450msec), or prolonged QRS interval.
  17. Patients who have suffered a myocardial infarction within the past 12 months, with uncompensated heart failure, or a history of QTc prolongation.
  18. Patients with abnormal serum potassium or magnesium levels upon screening.
  19. Patients currently taking other drugs that prolong the QTc including dofetilide, sotalol, quinidine, class Ia antiarrhythmics, class III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron methylate, probucol or tacrolimus.
  20. Patients who have failed to experience significant clinical improvement following 3 or more antidepressant trials of adequate duration (at least 6 weeks) and dose (minimal effective doses defined as: fluoxetine, paroxetine, citalopram 20mg; sertraline, fluvoxamine 50mg, escitalopram 10mg, paroxetine CR 25mg, venlafaxine 75mg, duloxetine 60mg, bupropion 150mg, 15mg of mirtazapine, trazodone or nefazodone 300mg).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555997

Contacts
Contact: Jonah Abrams, B.A.     (617)643-4559     jabrams33@partners.org    
Contact: George I Papakostas, M.D.     617-726-6697     gpapakostas@partners.org    

Locations
United States, California
Cedars-Sinai Medical Center     Recruiting
      Los Angeles, California, United States, 90048
      Contact: Lindsay Crist         Lindsay.Crist@cshs.org    
      Principal Investigator: Waguih IsHak, M.D.            
United States, Connecticut
University of Connecticut Health Center     Recruiting
      Farmington, Connecticut, United States, 06030-6415
      Contact: Andrew Winoker, M.D., PhD     860-679-6771     winokur@psychiatry.uchc.edu    
      Contact: Pamela Johnson     (860)679-6776     "kryzkowski@psychiatry.uchc.edu    
      Principal Investigator: Andrew Winoker, M.D.            
United States, Illinois
Psychiatric Medicine Associates, L.L.C.     Recruiting
      Chicago, Illinois, United States, 60612
      Contact: Ian Mackey         Ian_V_Mackey@rush.edu    
      Principal Investigator: John M Zajecka, M.D.            
United States, Massachusetts
Massachusetts General Hosptial     Not yet recruiting
      Boston, Massachusetts, United States, 02114
      Contact: Daniel P Johnson, B.A.     617-724-3673     djohnson31@partners.org    
      Principal Investigator: George Papakostas I Papakostas, M.D.            
Cambridge Health Alliance     Active, not recruiting
      Cambridge, Massachusetts, United States, 02139
United States, Tennessee
Vanderbilt University Medical Center     Recruiting
      Nashville, Tennessee, United States, 37212
      Contact: Richard C Shelton         richard.shelton@Vanderbilt.edu    
      Principal Investigator: Richard C Shelton, M.D.            

Sponsors and Collaborators
Massachusetts General Hospital
Cambridge Health Alliance
University of Connecticut
Vanderbilt University
Psychiatric Medicine Associates, L.L.C.
Cedars-Sinai Medical Center

Investigators
Principal Investigator:     George I Papakostas, M.D.     Massachusetts General Hospital    
Principal Investigator:     John M Zajecka, M.D.     Psychiatric Medicine Associates, L.L.C.    
Principal Investigator:     Richard C Shelton, M.D.     Vanderbilt University    
Principal Investigator:     Andrew Winokur, M.D.     University of Connecticut Health Center    
Principal Investigator:     Gustavo Kinrys, M.D.     Cambridge Health Alliance    
Principal Investigator:     Waguih IsHak, M.D.     Cedar's Sinai    
  More Information

Depression Clinical and Research Program at MGH  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Massachusetts General Hospital, Boston, MA 02114 ( George I Papakostas, M.D. )
Study ID Numbers:   2007-P-000623
First Received:   November 7, 2007
Last Updated:   June 6, 2008
ClinicalTrials.gov Identifier:   NCT00555997
Health Authority:   United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Major Depressive Disorder  
Major Depression  
Depression  
Geodon  
Ziprasidone  

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Ziprasidone
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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