Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 104
- 试验地点
- 17
- 主要终点
- Risk of relapse
研究概览
简要总结
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.
The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
详细描述
Randomized, open label, multicenter, phase III clinical trial. Number of subjects: 104. Age range: 18 - 55 years of both sex.
Timepoints for evaluation: Every two weeks, during the first six months after initiation of treatment discontinuation/continuation. Every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age from 18 to 55 years old
- •Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- •Antipsychotic treatment for 12 months since clinical stabilization. Clinical stabilization is defined in case of admission by medical discharge (not including voluntary discharge). In case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family.
- •No changes in the antipsychotic doses in the last 4 months.
- •No suicide attempts in the last 12 months.
- •Patient who shows remission criteria.
- •Signed informed consent form.
排除标准
- •Patient who is not fluent in Spanish language
- •Patient who takes mood stabilizers (Lithium, antiepileptic drugs...)
- •Dependency on alcohol or other substances of abuse (cannabis, cocaine...)
- •History of brain injury with loss of consciousness for more than 1 hour, stroke or other central nervous system disorders.
- •Intelligence testing (IQ) less than
- •Suicide attempt from stabilization.
- •Pregnancy or planning to become pregnant during the study.
研究组 & 干预措施
Antipsychotic treatment
Antipsychotic treatment according to common clinical practice
Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine, Pipotiazine, Flufenazine, Periciazine, Clozapine, Pimozide, Perfenazine, Sertindole, Levomepromazine, Amisulpride, Asenapine, Tiapride, Droperidol, Ziprasidone.
干预措施: Antipsychotic treatment (Drug)
Discontinuation antipsychotic treatment
Dose reduction of antipsychotic treatment (25% every 4 weeks).
干预措施: Discontinuation antipsychotic treatment (Drug)
结局指标
主要结局
Risk of relapse
时间窗: 12 months
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.
次要结局
未报告次要终点