DECIFER: DEpression and Citalopram In First Episode Recovery
This study is currently recruiting participants.
Verified September 2012 by New York University School of Medicine
Sponsor:
New York University School of Medicine
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: September 18, 2012
Last verified: September 2012
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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, Weeks 0-4, 6, 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, Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Weeks 0, 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, Weeks 0-4, 6, 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: Weeks 0, 8, 16, 24, 32, 40, 52 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (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.
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: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female
- Ages 18-40 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.
- Serious suicide attempt within three years or ANY suicide attempt for subjects age 18-25.
- Active alcohol or other substance abuse or dependence within three months
- Unstable medical illness
- History of SSRI intolerance
- Pregnant or nursing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041274
Contacts
| Contact: Jessie Rector, BA | 646-754-4803 | Jessie.Rector@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: | September 18, 2012 |
| 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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013