DECIFER: Depression and Citalopram In First Episode Recovery
Condition: Schizophrenia; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Citalopram; Placebo; Psychoeducation; Cognitive Behavioral Therapy (CBT); Functional Magnetic Resonance Imaging (fMRI)
Intervention description: 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
Intervention MeSH terms: Citalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Schizophrenia; Citalopram; First episode; fMRI; Cognitive behavioral therapy; Psychoeducation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Ages 16-40 years

          -  Schizophrenia, any subtype or Schizophreniform disorder

          -  Treated with any of the following second generation antipsychotics for at least 4
             weeks and fewer than 16 weeks: risperidone, olanzapine, quetiapine, aripiprazole,
             ziprasidone, or paliperidone)

          -  Willing to participate in psychoeducation

          -  Sufficient proficiency in English to complete assessments

        Exclusion Criteria:

          -  Major depression by DSM-IV criteria

          -  Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater.

          -  Calgary Depression Scale for Schizophrenia (CDRS) score of 7 or greater

          -  Serious suicide attempt within three years or ANY suicide attempt for subjects age
             16-25.

          -  Current treatment with an MAOI or pimozide

          -  Active alcohol or other substance abuse or dependence within three months

          -  Unstable medical illness

          -  History of SSRI intolerance

          -  Pregnant or nursing

          -  QTc ≥ 500 msec