DECIFER: Depression and Citalopram In First Episode Recovery

NCT01041274 | Completed Phase 4 Results DMC

• 2 other identifiers: 12-019651R01MH084900-01A1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizophreniform Disorder

Keywords

Schizophrenia; Citalopram; First episode; fMRI; Cognitive behavioral therapy; Psychoeducation

Outcome Measures

Primary Outcomes (1)

• Calgary Depression Scale for Schizophrenia (CDSS)

  The Calgary Depression Scale for Schizophrenia (CDSS) is a rater-administered assessment that measures depression in schizophrenia. The scale consists of 9 questions each rated 0 to 3. 0 corresponds with "absent" and 3 corresponds with "severe". The total score for all items is provided for each time point. The minimum score is 0 and the maximum score is 27. A higher score indicates increased depressive symptoms.

  Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Secondary Outcomes (4)

• Scale for the Assessment of Negative Symptoms (SANS)

  Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24, 28,32, 36, 40, 44, 48, 52

• Brief Psychiatric Rating Scale (BPRS)

  Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

• InterSePT Scale for Suicidal Thinking (ISST)

  Screening, Baseline, Weeks 1-8

• Heinrich Quality of Life Scale (QOL)

  Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52

Study Arms (2)

Citalopram

EXPERIMENTAL

Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Participants will receive a daily dose of placebo for 12 months.

Drug: Placebo; Behavioral: Psychoeducation; Behavioral: Cognitive Behavioral Therapy (CBT); Radiation: Functional Magnetic Resonance Imaging (fMRI)

Interventions

Citalopram DRUG

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.

Also known as: Celexa, Cipramil

Citalopram

Placebo DRUG

Placebo by mouth daily for 12 months.

Also known as: Sugar pill

Placebo

Psychoeducation BEHAVIORAL

16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions

Also known as: Therapy

Placebo

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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

Also known as: Therapy

Placebo

Functional Magnetic Resonance Imaging (fMRI) RADIATION

3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52

Also known as: Neuroimaging

Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York University Langone Medical Center/ Bellevue Hospital

New York, New York, 10016, United States

Location

Related Publications (1)

• Wang J, Hart KL, Qi W, Ardekani BA, Li C, Marx J, Freudenreich O, Cather C, Holt D, Bello I, Diminich ED, Tang Y, Worthington M, Zeng B, Wu R, Fan X, Zhao J, Wang J, Goff DC. Association of Aripiprazole With Reduced Hippocampal Atrophy During Maintenance Treatment of First-Episode Schizophrenia. J Clin Psychopharmacol. 2021 May-Jun 01;41(3):244-249. doi: 10.1097/JCP.0000000000001391.

  PMID: 33814546 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Citalopram; Dexetimide; Sugars; Therapeutics; Cognitive Behavioral Therapy; Neuroimaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Carbohydrates; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Results Point of Contact

• Title: Principal Investigator
• Organization: NYU Langone Medical Center

donald.goff@nyumc.org

646-754-4843

Study Officials

• Donald C Goff, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: December 31, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: March 26, 2018
• Last Updated: December 17, 2019
• Results First Posted: November 16, 2018

Record last verified: 2019-12

Locations

US (1)