Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

NCT ID: NCT00340379

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2005-08-31

Brief 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.

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.

Conditions

Affective Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ziprasidone

Subjects in this arm received ziprasidone with a placebo to maintain the blind

Group Type: ACTIVE_COMPARATOR

Ziprasidone

Intervention Type: DRUG

Target dosage 120-160mg/day based on tolerance

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.

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

Target dosage 150-200mg/day based on tolerance.

Haloperidol

Intervention Type: DRUG

Target dosage 6-8mg/day based on tolerance.

Interventions

Ziprasidone

Target dosage 120-160mg/day based on tolerance

Intervention Type: DRUG

Sertraline

Target dosage 150-200mg/day based on tolerance.

Intervention Type: DRUG

Haloperidol

Target dosage 6-8mg/day based on tolerance.

Intervention Type: DRUG

Other Intervention Names

Geodon; Zoloft; Haldol

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Cassidy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

George Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Ranga Krishnan, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Sumant Khanna, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neuroscience

Adel Elsheshai, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

University of Southern California

Los Angeles, California, United States

Alexandria University

Alexandria, , Egypt

National Institute of Mental Health and Neuroscience

Bangalore, , India

Countries

United States; Egypt; India

Other Identifiers

3846-05-6R2

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00008437

Identifier Type: -

Identifier Source: org_study_id