Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Condition(s) targeted: Affective Disorders

Intervention: Ziprasidone (Drug); Sertraline (Drug); Haloperidol (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Frederick Cassidy, MD, Principal Investigator, Affiliation: Duke University
George Simpson, MD, Principal Investigator, Affiliation: University of Southern California
Ranga Krishnan, MD, Principal Investigator, Affiliation: Duke University
Sumant Khanna, MD, Principal Investigator, Affiliation: National Institute of Mental Health and Neuroscience
Adel Elsheshai, MD, Principal Investigator, Affiliation: Alexandria University

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

21 item Hamilton Depression Rating Scale

Clinical Global Impression Improvement Scale

Brief Psychiatric Rating Scale at 12 weeks

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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)

Alexandria University, Alexandria, Egypt

National Institute of Mental Health and Neuroscience, Bangalore 560029, India

University of Southern California, Los Angeles, California 90033, United States

Starting date: April 2003
Ending date: August 2005
Last updated: July 31, 2007