Antidepressant controlled trial for negative symptoms in schizophrenia (ACTIONS) - Antidepressant controlled trial for negative symptoms in schizophrenia

Phase 1

• Conditions: Schizophrenia characterised by persistent negative symptoms

• Registration Number: EUCTR2009-009235-30-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-19
• Study Completion: 2014-12-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

Patients must meet the following criteria to be eligible for enrolment: 1. An OPCRIT (Operational Criteria Checklist for Psychosis: 57) diagnosis of schizophrenia, schizophreniform, schizoaffective disorder or psychosis NOS as defined by DSM-IV. 2. 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. Negative symptoms that reflect, sometimes very subtly, manifestations of depressive symptoms, antipsychotic side effects such as bradykinesia, or positive symptoms, are referred to as secondary negative symptoms, and the assessors will attempt to distinguish these from primary negative symptoms. However, persistent negative symptoms will be used as an inclusion criterion rather than primary negative symptoms, as the former are the clinically-relevant target, and the latter represent a hypothesis about aetiology that cannot be definitely determined on cross-sectional assessment. 3. Age 18-65 years, inclusive 4. Clinically stable for the last 3 months with a consistent antipsychotic regimen. 5. Competent and willing to provide written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Any of the following criteria will exclude a patient from the study: 1. Any medical contraindications to an SSRI antidepressant. 2. Taking any drug that risks interaction with citalopram (see citalopram SmPC and Appendix 3), e.g. pimozide, MAOIs, metoprolol, St John’s Wort (Hypericum perforatum), lithium, tryptophan, anticonvulsants, insulin, other medicines for diabetes, anticoagulants, regular aspirin or non-steroidal anti-inflammatory drugs such as ibuprofen, serotonergic drugs, such as tramadol and sumatriptan including those that may prolong the QT interval e.g. cimetidine, CYP3A4 and 2C19 inhibitors except antipsychotics other than pimozide (See appendix 4 for a full list of drugs other than antipsychotics that are known to prolong the QTc). 3. known QT interval prolongation or congenital long QT syndrome; congestive heart failure, bradyarrhythmias 4. Serum potassium and/or magnesium levels below the lower limits of normal. 5. Currently receiving any antidepressant drug or clinician wants to treat with an antidepressant. 6. Currently fulfil criteria for major depressive disorder; alcohol/substance hazardous use or dependence in past 3 months 7. Pregnancy or planning to become pregnant. 8. Treated with ECT in the last 8 weeks. 9. Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures. 10. Lack of capacity, as judged by the patient’s psychiatrist.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified