Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Affective Disorders Clinical Trial

Official title:

A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00340379
• Other study ID #: Pro00008437
• Secondary ID: 3846-05-6R2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 20, 2006
• Last updated: August 15, 2014
• Start date: April 2003
• Est. completion date: August 2005

Study information

• Verified date: February 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEgypt: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males or females, aged 18-70 years

• If female, must state willingness to use medically accepted methods of birth control (if of reproductive age) and have negative pregnancy test

• Ability to understand study procedures and provide written informed consent

• A DSM-IV diagnosis of Major Depressive Disorder, with psychotic features, based on the Structured Clinical Interview for DSM-IV (SCID)

• Hamilton Depression Rating Scale score (21-item HDRS) greater than or equal to 22

Exclusion Criteria:

• A current or lifetime DSM-IV diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder

• A DSM-IV diagnosis of alcohol or substance abuse or dependence within 3 months of study entry

• A QTc greater than 460 msec or an abnormal EKG (except minor abnormalities considered by the site investigator to be clinically insignificant)

• A heart rate less than or equal to 50

• A personal or family history of QTc

• Any current or past history of syncope

• Concurrent treatment with medications associated with prolongation of the QTc

• Concurrent treatment with medications that may affect magnesium or potassium, such as diuretics

• Any acute, unstable or serious medical illness (eg, AIDS, history of seizures, history of CVAs).

• Baseline blood chemistries that are outside local reference ranges and which are felt clinically significant by the site investigator, or a potassium, magnesium or calcium level outside of local reference ranges or liver function tests that are greater than 20% above the upper limit of local reference ranges. If magnesium and/or potassium are below the lower limit of the local laboratory norm, they may be repeated and rechecked during the screening phase, and if within laboratory norms, the subjects may be included.

• History of unstable cardiovascular disease

• A significant risk of suicide in the judgement of the site investigator

• A history of allergy or hypersensitivity to haloperidol, sertraline or ziprasidone

• Any history of neuroleptic malignant syndrome

• Treatment with sertraline or ziprasidone within 30 days of study entry

• History of recent treatment with any long acting psychotropic medications

• Treatment with a MAO-inhibitor within 14 days of study entry

• Treatment with an investigational drug within 30 days of study entry

• Current use of carbamazepine, nefazodone, ketoconazole or erythromycin

• A positive pregnancy test

• A positive drug screen unless attributable to a prescribed medication (e.g. benzodiazepines)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Affective Disorders
• Mood Disorders

Intervention

Drug:
• Ziprasidone
Target dosage 120-160mg/day based on tolerance
• Sertraline
Target dosage 150-200mg/day based on tolerance.
• Haloperidol
Target dosage 6-8mg/day based on tolerance.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria
India	National Institute of Mental Health and Neuroscience	Bangalore
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health and Neuro Sciences, India, Pfizer

Countries where clinical trial is conducted

United States,  Egypt,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	21 Item Hamilton Depression Rating Scale	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).	12 week	No
Primary	Clinical Global Impression Improvement Scale	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).	12 weeks	No
Primary	Brief Psychiatric Rating Scale at 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.	12 weeks	No