DECIFER: DEpression and Citalopram In First Episode Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Donald Goff, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01041274
First received: December 30, 2009
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizophreniform Disorder
Drug: Citalopram
Behavioral: Psychoeducation
Behavioral: Cognitive Behavioral Therapy (CBT)
Radiation: Functional Magnetic Resonance Imaging (fMRI)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citalopram in First Episode Schizophrenia

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24, 28,32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
  • InterSePT Scale for Suicidal Thinking (ISST) [ Time Frame: Screening, Baseline, Weeks 1-8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
  • Heinrich Quality of Life Scale (QOL) [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citalopram
Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.
Drug: Citalopram
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.
Other Names:
  • Celexa
  • Cipramil
Behavioral: Psychoeducation
16 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.
Placebo Comparator: Placebo
Participants will receive a daily dose of placebo for 12 months.
Drug: Placebo
Placebo by mouth daily for 12 months.
Behavioral: Psychoeducation
16 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041274

Contacts
Contact: Pamela Rakhshan, BA 646-754-4803 Pamela.Rakhshan@nyumc.org
Contact: Iruma Bello, PhD 646-754-4810 Iruma.Bello@nyumc.org

Locations
United States, New York
New York University Langone Medical Center/ Bellevue Hospital Recruiting
New York, New York, United States, 10016
Principal Investigator: Donald C Goff, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Donald C Goff, MD New York University Langone Medical Center
  More Information

No publications provided

Responsible Party: Donald Goff, Vice Chair for Research in Psychiatry, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01041274     History of Changes
Other Study ID Numbers: 2009-P-001342, 1R01MH084900-01A1
Study First Received: December 30, 2009
Last Updated: May 13, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Schizophrenia
Citalopram
First episode
fMRI
Cognitive behavioral therapy
Psychoeducation

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 22, 2014