Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression - Full Text View

Sponsor:	Duke University
Collaborators:	Pfizer National Institute of Mental Health and Neuro Sciences, India
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00340379

Purpose

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.

Condition	Intervention	Phase
Affective Disorders	Drug: Ziprasidone Drug: Sertraline Drug: Haloperidol	Phase II Phase III

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Disorders Psychotic Disorders

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Sertraline hydrochloride Sertraline Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

21 item Hamilton Depression Rating Scale [ Time Frame: 12 week ] [ Designated as safety issue: No ]
Clinical Global Impression Improvement Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Brief Psychiatric Rating Scale at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	April 2003
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ziprasidone	Drug: Ziprasidone
Active Comparator: Sertraline/Haloperidol	Drug: Sertraline Drug: Haloperidol

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340379

Locations

United States, California
University of Southern California
Los Angeles, California, United States, 90033
Egypt
Alexandria University
Alexandria, Egypt
India
National Institute of Mental Health and Neuroscience
Bangalore, India, 560029

Sponsors and Collaborators

Duke University

Pfizer

National Institute of Mental Health and Neuro Sciences, India

Investigators

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

More Information

No publications provided

Responsible Party:	Dr. Frederick Cassidy, Duke University
ClinicalTrials.gov Identifier:	NCT00340379 History of Changes
Other Study ID Numbers:	3846-05-6R2
Study First Received:	June 20, 2006
Last Updated:	August 4, 2009
Health Authority:	United States: Institutional Review Board; Egypt: Institutional Review Board; India: Institutional Review Board

Keywords provided by Duke University:

Psychotic

Additional relevant MeSH terms:

Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Haloperidol
Haloperidol decanoate
Ziprasidone
Sertraline
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antidepressive Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012