Clinical trial NCT01032083: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: SSRI antidepressant
Negative symptoms
Schizophrenia
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: University of Southampton
name: King's College London
name: University of Oxford
name: University College, London
name: University of Bristol
First posted: 2009-12-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PANSS Negative Symptom Score
timeFrame: 12 weeks
measure: Heinrich's Quality of Life Scale Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Avon and Wiltshire mental health partnership
city: Derby
country: United Kingdom
facility: Derbyshire healthcare NHS foundation trust
city: Lincoln
country: United Kingdom
facility: Lincolnshire partnership NHS foundation trust
city: London
country: United Kingdom
facility: West london Mental Health Trust
city: London
country: United Kingdom
facility: Camden and Islington NHS foundation trust
city: London
country: United Kingdom
facility: Central and North West London NHS foundation trust
city: London
country: United Kingdom
facility: Oxleas NHS foundation trust
city: London
country: United Kingdom
facility: South London and the Maudsley
city: Manchester
country: United Kingdom
facility: Manchester health and social care trust
city: Newcastle
country: United Kingdom
facility: Northumberland, Tyne and Wear NHS foundation trust
city: Oxford
country: United Kingdom
facility: Oxfordshire and Buckinghamshire NHS foundation trust
city: Sheffield
country: United Kingdom
facility: Sheffield social care foundation trust
city: Southampton
country: United Kingdom
facility: Southern Health
city: Stafford
country: United Kingdom
facility: South Staffordshire and Shropshire NHS foundation trust
Study officials:
affiliation: Imperial College London
name: Thomas R Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes TR, Leeson VC, Paton C, Costelloe C, Simon J, Kiss N, Osborn D, Killaspy H, Craig TK, Lewis S, Keown P, Ismail S, Crawford M, Baldwin D, Lewis G, Geddes J, Kumar M, Pathak R, Taylor S. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial. Health Technol Assess. 2016 Apr;20(29):1-46. doi: 10.3310/hta20290.