At a glance
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Citalopram in First Episode Schizophrenia
In Brief
A Phase 4 clinical trial evaluating Citalopram, Placebo, and 3 other interventions for Schizophrenia and Schizophreniform Disorder. Completed, enrolled 95 participants across 1 site.
Detailed Summary
This study seeks to examine the effectiveness of citalopram added to treatment with any oral or injectable second-generation antipsychotic plus standardized psychoeducation in first episode schizophrenia patients. Because depressive symptoms are common in first episode patients, we will test the hypothesis that adding the SSRI citalopram to a pre-established medication regimen will improve quality of life and decrease relapse and suicidality over the course of a 12-month trial.
Study Details
Timeline
Interventions
40 mg by mouth daily for 12 months. Dosing will start at 20mg daily and may be increased after a minimum of one week to the target dose of 40 mg daily. Dose decreases will be made in the presence of side effects. Allowed dose range will be 10 mg daily to 40 mg daily.
Placebo by mouth daily for 12 months.
16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions
Participants who exhibit symptoms of moderate suicidality at any point during the trial will be treated with 12 sessions of CBT, either once or twice weekly based on clinical judgment. Participants who continue to exceed suicidality criteria after 4 weeks of CBT will be dropped from double-blind treatment and may be prescribed openly an SSRI
3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52