Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia (ACTIONS)

Imperial College London

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Citalopram

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01032083

CRO 1250

2009-009235-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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