DECIFER: DEpression and Citalopram In First Episode Recovery - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	Donald C. Goff, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01041274

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 IV

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:

MedlinePlus related topics: Depression MRI Scans Schizophrenia

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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

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:	15 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female
Ages 15-40 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 15-25.
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: Gail Galendez, BA	617-912-7845	ggalendez@partners.org
Contact: Corinne Cather, PhD	617-912-7891	ccather@partners.org

Locations

United States, Massachusetts
Massacusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Donald C Goff, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Donald C Goff, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Donald C. Goff, Director, Schizophrenia Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01041274 History of Changes
Other Study ID Numbers:	2009-P-001342, 1R01MH084900-01A1
Study First Received:	December 30, 2009
Last Updated:	December 20, 2011
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Institute of Mental Health (NIMH):

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 February 09, 2012