NCT02569307

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• At Risk Mental State (ARMS)
• Psychosis

Interventions

Type	Name	Description
DRUG	Minocycline	Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
DRUG	Omega-3 fatty acids	Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
DRUG	Placebo	Placebo added to TAU
DRUG	Minocycline Plus Omega-3 fatty acids	Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2015-10-06
• Last updated: 2019-08-05

Locations

7 sites across 1 country: Pakistan