Conditions: Affective Disorders
Keywords: Psychotic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

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.

Arms:
arm 1: Subjects in this arm received ziprasidone with a placebo to maintain the blind arm 2: 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.

Interventions: intervention 1: Ziprasidone intervention 2: Sertraline intervention 3: Haloperidol
Intervention descriptions: intervention 1: Target dosage 120-160mg/day based on tolerance intervention 2: Target dosage 150-200mg/day based on tolerance. intervention 3: Target dosage 6-8mg/day based on tolerance.

Protocol document: