We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

DECIFER: Depression and Citalopram In First Episode Recovery (DECIFER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01041274
Recruitment Status : Active, not recruiting
First Posted : December 31, 2009
Last Update Posted : January 6, 2017
Information provided by (Responsible Party):

Study Description
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.

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citalopram in First Episode Schizophrenia
Study Start Date : December 2009
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Placebo Comparator: Placebo
Participants will receive a daily dose of placebo for 12 months.
Drug: Placebo
Placebo by mouth daily for 12 months.
Other Name: Sugar pill
Behavioral: Psychoeducation
16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions
Other Name: Therapy
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
Other Name: Therapy
Radiation: Functional Magnetic Resonance Imaging (fMRI)
3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Other Name: Neuroimaging

Outcome Measures

Primary Outcome Measures :
  1. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  3. InterSePT Scale for Suicidal Thinking (ISST) [ Time Frame: Screening, Baseline, Weeks 1-8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
  4. Heinrich Quality of Life Scale (QOL) [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041274

United States, New York
New York University Langone Medical Center/ Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Donald C Goff, MD New York University School of Medicine
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01041274     History of Changes
Other Study ID Numbers: 12-01965
1R01MH084900-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by New York University School of Medicine:
First episode
Cognitive behavioral therapy

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents