A Randomised Double Blind Placebo Controlled Pilot Study of Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 7
- 主要终点
- Transition to psychotic disorder
研究概览
简要总结
This is a randomized double-blind placebo controlled trial which aims to evaluate the efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS. Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to Treatment as Usual in an operationalized ARMS population in Pakistan:
详细描述
Primary hypothesis is that the persons with ARMS who are prescribed minocycline and / or Omega-3 fatty acids will have reduced transition rates to psychosis over a one year follow up period (from baseline) compared with Treatment-As-Usual (TAU). The transition rates will be lowest in the group receiving minocycline and Omega-3 fatty acids in combination.
Secondary objective is to determine that the Persons with ARMS who are prescribed minocycline and / or Omega-3fatty acids in combination will have greatest symptom reduction compared with TAU.
This study will be a six-month intervention of minocycline and/or Omega-3 fatty acids added to TAU in patients with ARMS, using a randomised, placebo-controlled, double-blind factorial design.The study will be a four-arm trial: one arm will receive minocycline with TAU; the second arm will receive Omega-3 fatty acids with TAU; the third arm will receive both minocycline and Omega-3 fatty acids with TAU; the fourth arm will receive placebo with TAU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female help seeking individuals aged between 16-35 years.
- •Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).
- •Assessed as competent to provide informed consent.
排除标准
- •History ofpreviously experiencing a psychotic illness (treated or untreated).
- •IQ < 70 and/or history of learning disability.
- •Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.
- •Organic brain disease e.g. epilepsy.
- •treatment with an antipsychotic or mood-stabilising agent.
- •Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.
- •Concomitant penicillin therapy or concomitant anticoagulant therapy.
- •Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
- •Treatment with warfarin or lamotrigine.
- •Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.
- •Current treatment with any anti-inflammatory medication.
- •Treatment with electroconvulsive therapy within the 12 weeks preceding the study.
- •Active expression of suicidal ideation (CAARMS item 7.3 severity score 6) or current aggression/dangerous behaviour (CAARMS item 5.4 severity score 6).
- •Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.
- •Pregnant or breastfeeding females.
研究组 & 干预措施
Placebo
Placebo added to TAU
干预措施: Placebo (Drug)
Minocycline
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
干预措施: Minocycline (Drug)
Omega-3 fatty acids
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose
干预措施: Omega-3 fatty acids (Drug)
Minocycline Plus Omega-3 fatty acids
Minocycline+Omega-3 fatty acids added to TAU ,Minocyline will be administered in 200mg once daily dose and Omega-3 fatty acids 1.2 g taken as once daily dose
干预措施: Minocycline Plus Omega-3 fatty acids (Drug)
结局指标
主要结局
Transition to psychotic disorder
时间窗: 12 Months
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
次要结局
- Measured severity ofAt Risk of Mental State ( ARMS) symptoms(12 Months)