Schizophrenia | DECIFER: Depression and Citalopram In First Episode Recovery
Schizophrenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Citalopram40 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.
Drug:PlaceboPlacebo by mouth daily for 12 months.
Behavioral:Psychoeducation16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions
Behavioral:Cognitive Behavioral Therapy (CBT)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
Radiation:Functional Magnetic Resonance Imaging (fMRI)3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CitalopramParticipants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.
PlaceboParticipants will receive a daily dose of placebo for 12 months.
Start Date: January 2010
Completed Date: March 26, 2018
Phase: Phase 4
Primary Outcome: Calgary Depression Scale for Schizophrenia (CDSS)
Secondary Outcome: Scale for the Assessment of Negative Symptoms (SANS)
Study sponsors, principal investigator, and references
Principal Investigator: Donald C Goff, MD
Lead Sponsor: New York University School of Medicine
Collaborator: National Institute of Mental Health (NIMH)