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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- At Risk Mental State (ARMS)
- Sponsor
- Pakistan Institute of Living and Learning
- Enrollment
- 326
- Locations
- 7
- Primary Endpoint
- Transition to psychotic disorder
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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:
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Placebo
Placebo added to TAU
Intervention: Placebo
Minocycline
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Intervention: Minocycline
Omega-3 fatty acids
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose
Intervention: Omega-3 fatty acids
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
Intervention: Minocycline Plus Omega-3 fatty acids
Outcomes
Primary Outcomes
Transition to psychotic disorder
Time Frame: 12 Months
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
Secondary Outcomes
- Measured severity ofAt Risk of Mental State ( ARMS) symptoms(12 Months)