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Trial record 2 of 1306 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks

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

Tracking Information
First Submitted Date  ICMJE November 7, 2007
First Posted Date  ICMJE November 9, 2007
Results First Submitted Date  ICMJE July 9, 2013
Results First Posted Date  ICMJE July 3, 2014
Last Update Posted Date July 3, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Hamilton Depression Rating Scale (HAM-D-17) Scores [ Time Frame: 6 weeks ]
Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
Hamilton Depression Rating Scale (HAM-D-17) Scores [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00555997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • Responder/Non-responder [ Time Frame: 6 weeks ]
    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).
  • Change in 6-VAS-D Scores During Each Phase. [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
  • Responder/Non-responder [ Time Frame: 12 weeks ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
Official Title  ICMJE A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
    Other Name: Geodon
  • Drug: Placebo
    0mg Placebo per day. "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Patients in group 1 will receive Ziprasidone for the full 12 weeks of the study.
    Intervention: Drug: Ziprasidone
  • Active Comparator: 2
    Patients in Group 2 will receive placebo for the first 6 weeks of the study, then will receive Ziprasidone for the last 6 weeks.
    Intervention: Drug: Ziprasidone
  • Placebo Comparator: 3
    Patients in Group 3 will receive placebo for the full 12 weeks of the study.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2007)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555997
Other Study ID Numbers  ICMJE 2007-P-000623
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party George I. Papakostas, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Cambridge Health Alliance
  • University of Connecticut
  • Vanderbilt University
  • Psychiatric Medicine Associates, L.L.C.
  • Cedars-Sinai Medical Center
Investigators  ICMJE
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 Medical Center
Principal Investigator: Andrew Winokur, M.D. UConn Health
Principal Investigator: Gustavo Kinrys, M.D. Cambridge Health Alliance
Principal Investigator: Waguih IsHak, M.D. Cedar's Sinai
Principal Investigator: Mahmoud S Okasha, MD Comprehensive Psychiatric Care, Norwich CT
PRS Account Massachusetts General Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP