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:
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
326
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
Placebo added to TAU
Abasi Shaheed Hospital
Karachi, Sindh, Pakistan
Civil hospital Karachi
Karachi, Sindh, Pakistan
Karwn e Hayat
Karachi, Sindh, Pakistan
Colleges and Universities
Karachi, Sindh, Pakistan
Transition to psychotic disorder
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
Time frame: 12 Months
Measured severity ofAt Risk of Mental State ( ARMS) symptoms
Comprehensive Assessment of At-Risk Mental States (CAARMS) (Berger, GEet al2006).A semi-structured interview that assists in the identification of individuals at risk of developing a first-episode psychotic disorder and measured the severity of ARMS symptoms.
Time frame: 12 Months
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Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose
Community
Karachi, Sindh, Pakistan
General Practitioners (GPs)
Karachi, Sindh, Pakistan
Institute of Behavioral Sciences
Karachi, Sindh, Pakistan