Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol|
- 21 Item Hamilton Depression Rating Scale [ Time Frame: 12 week ] [ Designated as safety issue: No ]The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).
- Clinical Global Impression Improvement Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).
- Brief Psychiatric Rating Scale at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.
|Study Start Date:||April 2003|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Ziprasidone
Subjects in this arm received ziprasidone with a placebo to maintain the blind
Target dosage 120-160mg/day based on tolerance
Other Name: Geodon
Active Comparator: Sertraline/Haloperidol
Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.
Target dosage 150-200mg/day based on tolerance.
Other Name: ZoloftDrug: Haloperidol
Target dosage 6-8mg/day based on tolerance.
Other Name: Haldol
Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study.
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|National Institute of Mental Health and Neuroscience|
|Bangalore, India, 560029|
|Principal Investigator:||Frederick Cassidy, MD||Duke University|
|Principal Investigator:||George Simpson, MD||University of Southern California|
|Principal Investigator:||Ranga Krishnan, MD||Duke University|
|Principal Investigator:||Sumant Khanna, MD||National Institute of Mental Health and Neuroscience|
|Principal Investigator:||Adel Elsheshai, MD||Alexandria University|