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Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia (ACTIONS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Citalopram
Placebo
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring SSRI antidepressant, Negative symptoms, Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Avon and Wiltshire mental health partnership
  • Derbyshire healthcare NHS foundation trust
  • Lincolnshire partnership NHS foundation trust
  • West london Mental Health Trust
  • Camden and Islington NHS foundation trust
  • Central and North West London NHS foundation trust
  • Oxleas NHS foundation trust
  • South London and the Maudsley
  • Manchester health and social care trust
  • Northumberland, Tyne and Wear NHS foundation trust
  • Oxfordshire and Buckinghamshire NHS foundation trust
  • Sheffield social care foundation trust
  • Southern Health
  • South Staffordshire and Shropshire NHS foundation trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Citalopram

Placebo

Arm Description

An SSRI antidepressant

Outcomes

Primary Outcome Measures

Quality-of-life measured on the Heinrich's Quality of Life Scale

Secondary Outcome Measures

Depression assessed using the Calgary Depression Rating Scale for Schizophrenia.

Full Information

First Posted
August 4, 2009
Last Updated
March 25, 2015
Sponsor
Imperial College London
Collaborators
University of Manchester, University of Southampton, King's College London, University of Oxford, University College, London, University of Bristol
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1. Study Identification

Unique Protocol Identification Number
NCT01032083
Brief Title
Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia
Acronym
ACTIONS
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
University of Manchester, University of Southampton, King's College London, University of Oxford, University College, London, University of Bristol

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
SSRI antidepressant, Negative symptoms, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citalopram
Arm Type
Active Comparator
Arm Description
An SSRI antidepressant
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality-of-life measured on the Heinrich's Quality of Life Scale
Time Frame
3 months and 12 months
Secondary Outcome Measure Information:
Title
Depression assessed using the Calgary Depression Rating Scale for Schizophrenia.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Barnes, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avon and Wiltshire mental health partnership
City
Bristol
Country
United Kingdom
Facility Name
Derbyshire healthcare NHS foundation trust
City
Derby
Country
United Kingdom
Facility Name
Lincolnshire partnership NHS foundation trust
City
Lincoln
Country
United Kingdom
Facility Name
West london Mental Health Trust
City
London
ZIP/Postal Code
W6 8RP
Country
United Kingdom
Facility Name
Camden and Islington NHS foundation trust
City
London
Country
United Kingdom
Facility Name
Central and North West London NHS foundation trust
City
London
Country
United Kingdom
Facility Name
Oxleas NHS foundation trust
City
London
Country
United Kingdom
Facility Name
South London and the Maudsley
City
London
Country
United Kingdom
Facility Name
Manchester health and social care trust
City
Manchester
Country
United Kingdom
Facility Name
Northumberland, Tyne and Wear NHS foundation trust
City
Newcastle
Country
United Kingdom
Facility Name
Oxfordshire and Buckinghamshire NHS foundation trust
City
Oxford
Country
United Kingdom
Facility Name
Sheffield social care foundation trust
City
Sheffield
Country
United Kingdom
Facility Name
Southern Health
City
Southampton
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
South Staffordshire and Shropshire NHS foundation trust
City
Stafford
Country
United Kingdom

12. IPD Sharing Statement

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Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia

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