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Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia (ACTIONS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
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         
Oxleas NHS foundation trust Recruiting
London, United Kingdom
Principal Investigator: Carol Paton         
South London and the Maudsley Recruiting
London, United Kingdom
Principal Investigator: Tom Craig, PhD         
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         
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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014