SchizophreniaPhase 4ACTIONSNCT01032083
Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia
A Phase 4 study testing Citalopram in people with Schizophrenia, run by Imperial College London at 14 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- Jul 2011to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Avon and Wiltshire mental health partnership
Bristol
Derbyshire healthcare NHS foundation trust
Derby
Lincolnshire partnership NHS foundation trust
Lincoln
West london Mental Health Trust
London, W6 8RP
Camden and Islington NHS foundation trust
London
Central and North West London NHS foundation trust
London
Oxleas NHS foundation trust
London
South London and the Maudsley
London
Manchester health and social care trust
Manchester
Northumberland, Tyne and Wear NHS foundation trust
Newcastle
Oxfordshire and Buckinghamshire NHS foundation trust
Oxford
Sheffield social care foundation trust
Sheffield
Southern Health
Southampton, SO14 0YG
South Staffordshire and Shropshire NHS foundation trust
Stafford
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Citalopram, Placebo
- Keywords
- SSRI antidepressant, Negative symptoms, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Active comparator | An SSRI antidepressant Receives: Drug: Citalopram |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, University of Southampton, King's College London, University of Oxford, University College, London, University of Bristol
- Responsible party
- Sponsor
- Investigators
- Thomas R Barnes, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032083
- Sponsor's protocol ID
- CRO 1250
- Other IDs
- 2009-009235-30, 2009
- Acronym
- ACTIONS
- Status last verified
- Oct 2023
- First submitted
- 4 Aug 2009
- Last updated
- 28 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27094189
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01032083
- Acronym / sponsor ID
- ACTIONS / CRO 1250
- Conditions
- Schizophrenia
- Keywords
- SSRI antidepressant, Negative symptoms, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Manchester, University of Southampton, King's College London, University of Oxford, University College, London, University of Bristol
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 28 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Active comparator | Drug: CitalopramAn SSRI antidepressant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramTreatment 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. | Drug | Citalopram |
| PlaceboTreatment 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. | Drug | Placebo |
Primary outcome
PANSS Negative Symptom Score
Time frame: 12 weeks
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
Heinrich's Quality of Life Scale Score
Time frame: 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27094189Barnes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Barnes, MD principal investigator
Imperial College London
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Citalopram in people with Schizophrenia, run by Imperial College London at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS Negative Symptom Score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.