Conditions: Major Depressive Disorder With Psychotic Features
Keywords: Major depressive disorder with psychotic features Delusional Depression Randomized Trial Combination Treatment SSRI Atypical Antipsychotic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 259
Healthy volunteers: no

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

Detailed 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.

Arms:
arm 1: sertraline plus olanzapine arm 2: olanzapine (5 - 20mg/day) plus placebo

Interventions: intervention 1: Olanzapine intervention 2: Sertraline intervention 3: placebo
Intervention descriptions: intervention 1: 10-20mg/day intervention 2: 150-200mg/day intervention 3: tablet that ressembles sertraline but contains no medication

Protocol document: