Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder With Psychotic Features

Treatments: Other: placebo; Drug: Sertraline; Drug: Olanzapine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00056472

U01MH062446 (U.S. NIH Grant/Contract)

U01MH062565 (U.S. NIH Grant/Contract)

U01MH062518 (U.S. NIH Grant/Contract)

U01MH062624 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Full description

Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.

This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major depressive disorder, single or recurrent, with psychotic features

Exclusion criteria

• History of substance abuse or dependence within the 3 months prior to enrollment
• Acute or unstable medical illness
• Diagnosis of schizophrenia or other psychotic disorders
• Pregnant
• Intolerance to SSRIs or olanzapine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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259 participants in 2 patient groups, including a placebo group

olanzapine/sertraline combination

Active Comparator group

Description:

sertraline plus olanzapine

Treatment:

Drug: Olanzapine

Drug: Sertraline

olanzapine plus placebo

Placebo Comparator group

Description:

olanzapine (5 - 20mg/day) plus placebo

Treatment:

Drug: Olanzapine

Other: placebo