Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States — NAYAB  

Psychosis Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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:

Clinical Trial 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. ;

Related Conditions & MeSH terms

• At Risk Mental State (ARMS)
• Mental Disorders
• Psychosis
• Psychotic Disorders

• NCT number: NCT02569307
• Study type: Interventional
• Source: Pakistan Institute of Living and Learning
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Completion date: March 2019