DECIFER: Depression and Citalopram In First Episode Recovery (DECIFER)
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|ClinicalTrials.gov Identifier: NCT01041274|
Recruitment Status : Active, not recruiting
First Posted : December 31, 2009
Last Update Posted : April 5, 2018
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Citalopram in First Episode Schizophrenia|
|Actual Study Start Date :||December 2009|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||March 2020|
Participants will receive a daily dose of citalopram, with flexible dosing as determined by clinician, for 12 months.
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.
Placebo Comparator: Placebo
Participants will receive a daily dose of placebo for 12 months.
Placebo by mouth daily for 12 months.
Other Name: Sugar pillBehavioral: Psychoeducation
16 sessions of weekly, individual psychoeducation and relapse prevention planning followed by 8 monthly sessions
Other Name: TherapyBehavioral: 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: TherapyRadiation: Functional Magnetic Resonance Imaging (fMRI)
3 1-hour sessions of fMRI brain scanning, assessed at baseline, and weeks 24 and 52
Other Name: Neuroimaging
- Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
- 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 ]
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
- InterSePT Scale for Suicidal Thinking (ISST) [ Time Frame: Screening, Baseline, Weeks 1-8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
- Heinrich Quality of Life Scale (QOL) [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52 ]
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|
|Principal Investigator:||Donald C Goff, MD||New York University School of Medicine|