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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 14
- 主要终点
- PANSS Negative Symptom Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Citalopram
An SSRI antidepressant
干预措施: Citalopram (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
PANSS Negative Symptom Score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点