Department of psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Trials. 2013 Nov 27;14:406. doi: 10.1186/1745-6215-14-406.
Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available. Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive symptoms.In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications.
The study is a parallel group, double-blind, randomized, placebo-controlled trial. Participants will be adults (aged 18 years and above) with first episode or relapse episode of schizophrenia of under 5 years' duration. Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira, Ethiopia. A total of 150 participants (75 in each arm) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity, at 90% power and 95% confidence. Patients in the intervention arm will receive minocycline (200 mg/day orally) added on to the regular antipsychotic medications participants are already on. Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline. Intervention will be offered for 12 weeks. Diagnosis will be established using the operational criteria for research (OPCRIT). Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia (PANSS). Secondary outcome measures will include changes in severity of negative symptoms, proportion achieving remission, and level of functioning. Whether changes are maintained post intervention will also be measured (PANSS). Key assessment for the primary outcome will be conducted at the end of trial (week 12). One post-intervention assessment will be conducted 4 weeks after the end of intervention (week 16) to determine sustainability of change.
Clinicaltrials.gov identifier: NCT01809158.
精神分裂症被认为是一种具有重叠症状维度的异质脑疾病。阴性症状维度，其表现形式多样的认知症状，对治疗反应不佳，在氯氮平治疗不可用的国家可能是一个特别的挑战。初步数据表明，米诺环素可能是治疗精神分裂症的有益辅助药物：阳性、阴性和认知症状。本研究旨在评估辅助米诺环素减轻对至少一种抗精神病药物治疗反应不足的精神分裂症患者的症状。
该研究是一项平行组、双盲、随机、安慰剂对照试验。参与者将是患有首次发作或复发的精神分裂症患者，病程不到 5 年，年龄在 18 岁及以上。来自埃塞俄比亚亚的斯亚贝巴的一家精神病院和 Butajira 的一家精神病诊所招募那些对至少一种抗精神病药物治疗反应不足 4 周的患者。需要 150 名参与者（每组 75 名），以在 90%的功效和 95%的置信区间内，根据基线症状严重程度，检测干预组之间 5 分均值差异。干预组患者将接受米诺环素（每天 200 毫克口服），加入他们正在服用的常规抗精神病药物中。安慰剂组患者将接受一种与米诺环素在外观上相同的无活性化合物。干预将持续 12 周。诊断将使用研究操作标准（OPCRIT）确定。主要观察指标是使用阳性和阴性症状量表（PANSS）评估的症状严重程度变化。次要观察指标包括阴性症状严重程度变化、达到缓解的比例以及功能水平。还将测量干预后是否保持变化（PANSS）。主要结果指标的关键评估将在试验结束时（第 12 周）进行。干预结束后 4 周（第 16 周）进行一次干预后评估，以确定变化的可持续性。
Clinicaltrials.gov 标识符：NCT01809158。
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