Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
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|ClinicalTrials.gov Identifier: NCT00340379|
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : June 4, 2013
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Affective Disorders||Drug: Ziprasidone Drug: Sertraline Drug: Haloperidol||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
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: Zoloft
Target dosage 6-8mg/day based on tolerance.
Other Name: Haldol
- 21 Item Hamilton Depression Rating Scale [ Time Frame: 12 week ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340379
|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|