Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Citalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; Taking any medications that risk interacting with citalopram Known congenital long QT syndrome, congestive heart failure, bradyarrhythmias QT limit above the upper limit of normal as determined by an electrocardiogram (ECG) Serum potassium and/or magnesium levels below the lower limits of normal 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. Pregnant or planning to become pregnant Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures. Lack of consent, as judged by the patient's psychiatrist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Citalopram<br>An SSRI antidepressant | Drug: Citalopram<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-life measured on the Heinrich's Quality of Life Scale |  | 3 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression assessed using the Calgary Depression Rating Scale for Schizophrenia. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSRI antidepressant, Negative symptoms, Schizophrenia