Last updated on February 2018

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02569307

Contact Investigators or Research Sites near you

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Prof Munir Hamarani, FCPS

Abasi Shaheed Hospital
Karachi, Pakistan
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Prof Raza U Rahman, FCPS

Civil hospital Karachi
Karachi, Pakistan
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Dr Ajmal Kazmi

Karwn e Hayat
Karachi, Pakistan
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Dr.Inti Qurashi, MD

Colleges and Universities
Karachi, Pakistan
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Dr.Inti Qurashi, MD

Community
Karachi, Pakistan
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Dr.Jawahar Lal, FCPS

General Practitioners (GPs)
Karachi, Pakistan
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Shehla Ahmed

Institute of Behavioral Sciences
Karachi, Pakistan
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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