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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009235-30 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| University of Southampton | OTHER |
| King's College London | OTHER |
| University of Oxford |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citalopram | Active Comparator | An SSRI antidepressant |
|
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citalopram | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R Barnes, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avon and Wiltshire mental health partnership | Bristol | United Kingdom | ||||
| Derbyshire healthcare NHS foundation trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27094189 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Citalopram | Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period. |
| FG001 | Placebo | Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| OTHER |
| University College, London | OTHER |
| University of Bristol | OTHER |
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| Placebo | Drug | 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. |
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| Derby |
| United Kingdom |
| Lincolnshire partnership NHS foundation trust | Lincoln | United Kingdom |
| West london Mental Health Trust | London | W6 8RP | United Kingdom |
| Camden and Islington NHS foundation trust | London | United Kingdom |
| Central and North West London NHS foundation trust | London | United Kingdom |
| Oxleas NHS foundation trust | London | United Kingdom |
| South London and the Maudsley | London | United Kingdom |
| Manchester health and social care trust | Manchester | United Kingdom |
| Northumberland, Tyne and Wear NHS foundation trust | Newcastle | United Kingdom |
| Oxfordshire and Buckinghamshire NHS foundation trust | Oxford | United Kingdom |
| Sheffield social care foundation trust | Sheffield | United Kingdom |
| Southern Health | Southampton | SO14 0YG | United Kingdom |
| South Staffordshire and Shropshire NHS foundation trust | Stafford | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Citalopram | Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period. |
| BG001 | Placebo | Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Citalopram | Citalopram: 20mg/day for the first 4 weeks, followed by the option to increase the dose to 40mg per day for the remainder of the study period. | 0 | 30 | 0 | 30 | 8 | 30 |
| EG001 | Placebo | Placebo: one placebo capsule for the first 4 weeks, followed by the option to increase the dose to two placebo capsules for the remainder of the study period. | 0 | 32 | 0 | 32 | 11 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Thomas Barnes | Imperial College London | t.r.barnes@imperial.ac.uk |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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