Clinical trial NCT00340379: Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
Official title: A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Affective Disorders
Keywords: Psychotic
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: National Institute of Mental Health and Neuro Sciences, India
First posted: 2006-06-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 21 Item Hamilton Depression Rating Scale
timeFrame: 12 week
measure: Clinical Global Impression Improvement Scale
timeFrame: 12 weeks
measure: Brief Psychiatric Rating Scale at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Alexandria
country: Egypt
facility: Alexandria University
city: Bangalore
country: India
facility: National Institute of Mental Health and Neuroscience
Study officials:
affiliation: Duke University
name: Frederick Cassidy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: George Simpson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Ranga Krishnan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Mental Health and Neuroscience
name: Sumant Khanna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Adel Elsheshai, MD
role: PRINCIPAL_INVESTIGATOR
References: