Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia (ACTIONS)
This study is currently recruiting participants.
Verified November 2012 by Imperial College London
Sponsor:
Imperial College London
Collaborators:
University of Manchester
University of Southampton
King's College London
University of Oxford
University College, London
University of Bristol
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01032083
First received: August 4, 2009
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Citalopram Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Imperial College London:
Primary Outcome Measures:
- Quality-of-life measured on the Heinrich's Quality of Life Scale [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Depression assessed using the Calgary Depression Rating Scale for Schizophrenia. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 358 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Citalopram
An SSRI antidepressant
|
Drug: Citalopram
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.
|
| Placebo Comparator: Placebo |
Drug: Placebo
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.
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032083
Contacts
| Contact: Thomas R Barnes, MD | +44 2073861233 | t.r.barnes@imperial.ac.uk |
Locations
| United Kingdom | |
| Avon and Wiltshire mental health partnership | Recruiting |
| Bristol, United Kingdom | |
| Contact: Glyn Lewis | |
| Principal Investigator: Glyn Lewis, MB BS | |
| Sub-Investigator: Tim Peters, PhD | |
| Derbyshire healthcare NHS foundation trust | Recruiting |
| Derby, United Kingdom | |
| Principal Investigator: Rudresh Pathak | |
| Lincolnshire partnership NHS foundation trust | Recruiting |
| Lincoln, United Kingdom | |
| Principal Investigator: Rudresh Pathak | |
| Oxleas NHS foundation trust | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Carol Paton | |
| West london Mental Health Trust | Recruiting |
| London, United Kingdom, W6 8RP | |
| Contact: Thomas Barnes +44 2073861233 | |
| Contact: Alexa Duff +447 3861229 a.duff@imperial.ac.uk | |
| Principal Investigator: Thomas R Barnes, MD | |
| Sub-Investigator: Mike Crawford, MD | |
| Camden and Islington NHS foundation trust | Recruiting |
| London, United Kingdom | |
| Contact: David Osborn | |
| Principal Investigator: David Osborn, MB BS | |
| Principal Investigator: Helen Killaspy, MD | |
| Central and North West London NHS foundation trust | Not yet recruiting |
| London, United Kingdom | |
| Contact: Alexa Duff +44 207 3861229 a.duff@imperial.ac.uk | |
| Principal Investigator: Mike Crawford | |
| South London and the Maudsley | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Tom Craig, PhD | |
| Manchester health and social care trust | Recruiting |
| Manchester, United Kingdom | |
| Contact: Shon Lewis | |
| Principal Investigator: Shon Lewis, MD | |
| Northumberland, Tyne and Wear NHS foundation trust | Recruiting |
| Newcastle, United Kingdom | |
| Oxfordshire and Buckinghamshire NHS foundation trust | Recruiting |
| Oxford, United Kingdom | |
| Contact: John Geddes | |
| Principal Investigator: John Geddes, MD | |
| Sub-Investigator: Judit Simon, MD | |
| Sheffield social care foundation trust | Recruiting |
| Sheffield, United Kingdom | |
| Southern Health | Recruiting |
| Southampton, United Kingdom, SO14 0YG | |
| Contact: David Baldwin | |
| Principal Investigator: David Baldwin, MD | |
| South Staffordshire and Shropshire NHS foundation trust | Recruiting |
| Stafford, United Kingdom | |
Sponsors and Collaborators
Imperial College London
University of Manchester
University of Southampton
King's College London
University of Oxford
University College, London
University of Bristol
Investigators
| Principal Investigator: | Thomas R Barnes, MD | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01032083 History of Changes |
| Other Study ID Numbers: | CRO 1250, HTA 07/83/01, EudraCT 2009-009235-30 |
| Study First Received: | August 4, 2009 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Imperial College London:
|
SSRI antidepressant Negative symptoms Schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antidepressive Agents Citalopram Dexetimide Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 21, 2013