NCT01032083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2011

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

March 28, 2024

Completed
Last Updated

March 28, 2024

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

August 4, 2009

Results QC Date

March 13, 2019

Last Update Submit

October 5, 2023

Conditions

Schizophrenia

Keywords

SSRI antidepressantNegative symptomsSchizophrenia

Outcome Measures

Primary Outcomes (2)

  • PANSS Negative Symptom Score

    The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview to elicit symptom ratings for 30 symptoms of psychosis, each scored between 1-7. The negative symptoms subscale uses the individual items in the PANSS that Marder identified as negative symptom (blunted affect, emotional withdrawal, poor rapport, passive/ apathetic social withdrawal, motor retardation, active social avoidance and lack of spontaneity/flow of conversation). Scores on these individual items are summed to create the subscale score. The subscale has a range of 7 to 49, with higher scores indicate greater psychopathology

    12 weeks

  • Heinrich's Quality of Life Scale Score

    The Heinrichs Quality of Life scale is a 21-item scale based on a semi-structured interview designed to assess deficit symptoms. Each items is scored from 0-6 and the total score is the sum of all item responses. The total score has a range of 0 to 126, with higher scores indicating better functioning.

    12 weeks

Study Arms (2)

Citalopram

ACTIVE COMPARATOR

An SSRI antidepressant

Drug: Citalopram

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CitalopramDRUG

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.

Citalopram
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Avon and Wiltshire mental health partnership

Bristol, United Kingdom

Location

Derbyshire healthcare NHS foundation trust

Derby, United Kingdom

Location

Lincolnshire partnership NHS foundation trust

Lincoln, United Kingdom

Location

West london Mental Health Trust

London, W6 8RP, United Kingdom

Location

Camden and Islington NHS foundation trust

London, United Kingdom

Location

Central and North West London NHS foundation trust

London, United Kingdom

Location

Oxleas NHS foundation trust

London, United Kingdom

Location

South London and the Maudsley

London, United Kingdom

Location

Manchester health and social care trust

Manchester, United Kingdom

Location

Northumberland, Tyne and Wear NHS foundation trust

Newcastle, United Kingdom

Location

Oxfordshire and Buckinghamshire NHS foundation trust

Oxford, United Kingdom

Location

Sheffield social care foundation trust

Sheffield, United Kingdom

Location

Southern Health

Southampton, SO14 0YG, United Kingdom

Location

South Staffordshire and Shropshire NHS foundation trust

Stafford, United Kingdom

Location

Related Publications (1)

  • Barnes TR, Leeson VC, Paton C, Costelloe C, Simon J, Kiss N, Osborn D, Killaspy H, Craig TK, Lewis S, Keown P, Ismail S, Crawford M, Baldwin D, Lewis G, Geddes J, Kumar M, Pathak R, Taylor S. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial. Health Technol Assess. 2016 Apr;20(29):1-46. doi: 10.3310/hta20290.

    PMID: 27094189RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Professor Thomas Barnes
Organization
Imperial College London
t.r.barnes@imperial.ac.uk

Study Officials

  • Thomas R Barnes, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

December 15, 2009

Study Start

July 1, 2011

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

March 28, 2024

Results First Posted

March 28, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(14)