Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Citalopram

• Registration Number: NCT01032083
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Study Start: 2011-07
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Results First Submitted: 2019-03-13
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-05
• Results First Posted: 2024-03-28
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Citalopram	Citalopram	An SSRI antidepressant

Primary Outcome Measures

Name	Time	Method
PANSS Negative Symptom Score	12 weeks	The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview to elicit symptom ratings for 30 symptoms of psychosis, each scored between 1-7. The negative symptoms subscale uses the individual items in the PANSS that Marder identified as negative symptom (blunted affect, emotional withdrawal, poor rapport, passive/ apathetic social withdrawal, motor retardation, active social avoidance and lack of spontaneity/flow of conversation). Scores on these individual items are summed to create the subscale score. The subscale has a range of 7 to 49, with higher scores indicate greater psychopathology
Heinrich's Quality of Life Scale Score	12 weeks	The Heinrichs Quality of Life scale is a 21-item scale based on a semi-structured interview designed to assess deficit symptoms. Each items is scored from 0-6 and the total score is the sum of all item responses. The total score has a range of 0 to 126, with higher scores indicating better functioning.

Trial Locations

Locations (14)

Avon and Wiltshire mental health partnership; 🇬🇧 Bristol, United Kingdom

Lincolnshire partnership NHS foundation trust; 🇬🇧 Lincoln, United Kingdom

Manchester health and social care trust; 🇬🇧 Manchester, United Kingdom

Northumberland, Tyne and Wear NHS foundation trust; 🇬🇧 Newcastle, United Kingdom

Sheffield social care foundation trust; 🇬🇧 Sheffield, United Kingdom

Southern Health; 🇬🇧 Southampton, United Kingdom

South London and the Maudsley; 🇬🇧 London, United Kingdom

Oxfordshire and Buckinghamshire NHS foundation trust; 🇬🇧 Oxford, United Kingdom

South Staffordshire and Shropshire NHS foundation trust; 🇬🇧 Stafford, United Kingdom

Central and North West London NHS foundation trust; 🇬🇧 London, United Kingdom

Oxleas NHS foundation trust; 🇬🇧 London, United Kingdom

Derbyshire healthcare NHS foundation trust; 🇬🇧 Derby, United Kingdom

West london Mental Health Trust; 🇬🇧 London, United Kingdom

Camden and Islington NHS foundation trust; 🇬🇧 London, United Kingdom