Minocycline add-on Medication to Antipsychotics in the Treatment of Schizophrenia Patients: A Double- Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Scale for Assessment of Negative Symptoms (SANS)
研究概览
简要总结
Current medications have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. In the past years, various findings from clinical studies showed its potential role for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating positive, negative and cognitive symptoms in schizophrenia patients.The current study is a single center, double-blind, randomized study that assess the adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in adult patients suffering from schizophrenia. Patients will be recruited and randomly allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In addition, all patients will receive probiotics (450mg/day) in order to prevent any gastrointestinal influences of antibiotics administration. Positive and negative symptoms , as well as cognitive functions will be assessed before and after treatment.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18-60 years of age.
- •Diagnostic and Statistical Manual (DSM) 5 diagnosis of Schizophrenia/ Schizo effective disorder based on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) for schizophrenia and confirmed by two senior psychiatrists.
- •Initiated on treatment with stable dosage (within +/- 25%) of atypical anti-psychotic medication for at least 6 weeks.
- •Capable and willing to provide informed consent.
- •Able to adhere to the treatment schedule.
- •Able to read, hear, write and speak the local language.
- •Has signed a written informed consent to participate in the study.
排除标准
- •Patients with acute, unstable, or decompensated medical condition.
- •Present substance abuse.
- •Major depression (MDD) diagnosis.
- •Attention deficit/ hyperactivity disorder (ADHD/ADD) diagnosis.
- •Cognitive dysfunction, such as Alzheimer disease or retardation.
- •Acute psychotic state.
- •Aggressive or violent patient or with vast history of aggressive or violent behavior.
- •Diagnosis of Borderline/ Anti Social/ Narcissistic personality disorders.
- •Previous sensitivity to Minocycline.
- •Current suicidal ideation or history of a suicide attempt in the past three years
- •Known or suspected pregnancy or women of childbearing potential not using a medically accepted form of contraception .(if using oral contraceptives, during the Minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding.
- •Subjects who are taking a known contraindication to Minocycline treatment (anti-coagulants, other antibiotics (of the penicillin group), methoxyflurane, Isotretinoin).
- •Subjects who had received treatment with Minocycline or β-lactam antibiotics in the preceding half year before study entry.
- •Subjects who are under compulsory hospitalization.
- •Subjects with medical history of Intestinal disease, Peptic ulcer or gastritis.
研究组 & 干预措施
Minocycline treatment
Intervention: Drug: Minocycline (200 mg/day)
干预措施: Minocycline (Drug)
Minocycline treatment
Intervention: Drug: Minocycline (200 mg/day)
干预措施: Probiotics (Other)
Placebo treatment
Placebo Intervention: Drug: Placebo (200 mg/day)
干预措施: Placebo (Drug)
Placebo treatment
Placebo Intervention: Drug: Placebo (200 mg/day)
干预措施: Probiotics (Other)
结局指标
主要结局
Scale for Assessment of Negative Symptoms (SANS)
时间窗: Change in SANS scores over the 6-weeks study
Positive and Negative Syndrome Scale (PANSS)
时间窗: Change in PANSS scores over the 6-weeks study
次要结局
- Clinical Global Impressions (CGI)(Change in CGI scores over the 6-weeks study)
- The Montreal Cognitive Assessment (MoCa) task(Change in MoCa scores over the 6-weeks study)
- Trail making task (TMT)(Change in TMT scores over the 6-weeks study)
- Empathy Cartoon task(Change in Empathy Cartoon task scores over the 6-weeks study)
- Interpersonal Reactivity Index (IRI) Questionnaire(Change in IRI scores over the 6-weeks study)
研究者
Dr. Stryjer Rafael (MD)
Senior Psychatrist
Beer Yaakov - Ness Ziona Mental Health Center