Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia

Official Title: “Individually Randomised, Placebo-controlled, Parallel Arm RCT With 12-month Follow-up to Establish the Clinical and Cost Effectiveness of the Antidepressant Citalopram in the Management of Negative Symptoms of Schizophrenia”

The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of persistent negative symptoms of schizophrenia over a year.

The negative symptoms of schizophrenia represent an important dimension of psychopathology, and reflect the absence or diminution of normal behaviours and functions. They include deficiencies in emotional responsiveness, drive, and emotional and social engagement.

Persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome in patients with established schizophrenia, but if they prove resistant to antipsychotic medication there is a very limited evidence base regarding specific treatments. The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of negative symptoms of schizophrenia over a year. The study sample will be adults with a diagnosis of schizophrenia, clinically stable for 3 months with a consistent antipsychotic regimen, and characterised by persistent negative symptoms to a criterion level of severity.

Intervention(s) in this Clinical Trial

• Drug: Citalopram
  • Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.
• Drug: Placebo
  • Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Citalopram
  • An SSRI antidepressant
• Placebo Comparator: Placebo

Primary Measures

• Quality-of-life measured on the Heinrich's Quality of Life Scale
  • Time Frame: 3 months and 12 months
    Safety Issue?: No

Secondary Measures

• Depression assessed using the Calgary Depression Rating Scale for Schizophrenia.
  • Time Frame: 3 months
    Safety Issue?: No

Inclusion Criteria:

• An OPCRIT (Operational Criteria Checklist for Psychosis: 57) diagnosis of schizophrenia, schizophreniform, schizoaffective disorder or psychosis NOS as defined by DSM-IV.
• A negative subscale score of 20 or more on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS). At least three of the seven items on the negative symptom subscale should be rated 3 or more.
• Age 18-75 years, inclusive
• Clinically stable for the last 3 months with a consistent antipsychotic regimen.
• Competent and willing to provide written, informed consent.

Exclusion criteria:

• Any medical contraindications to an SSRI antidepressant.
• Currently receiving antidepressant or clinician wants to treat with an antidepressant;
• Currently fulfil criteria for major depressive disorder; alcohol/substance hazardous use or dependence in past 3 months
• Treated with ECT in the last 8 weeks.
• Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Imperial College London Other

Overall Clinical Trial Officials and Contacts

Thomas R Barnes, MD Principal Investigator Imperial College London  

Overall Contact: Thomas R Barnes, MD +44 2073861233 t.r.barnes@imperial.ac.uk

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01032083

Study ID Number: CRO 1250

ClinicalTrials.gov Identifier: NCT01032083

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency