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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline | Active Comparator | Minocycline added to TAU Minocycline will be administered in 200mg once daily dose |
|
| Omega-3 fatty acids | Active Comparator | Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose |
|
| Placebo | Active Comparator | Placebo added to TAU |
|
| Minocycline Plus Omega-3 fatty acids | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | Minocycline added to TAU Minocycline will be administered in 200mg once daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transition to psychotic disorder | Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
15. Pregnant or breastfeeding females.
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Inti Qurashi, MD | Manchester University ,UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abasi Shaheed Hospital | Karachi | Sindh | 72000 | Pakistan | ||
| Civil hospital Karachi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29121974 | Derived | Qurashi I, Chaudhry IB, Khoso AB, Farooque S, Lane S, Husain MO, Chu S, Sarginson J, Hamarani M, Naqvi HA, Razzaque B, Minhas FA, Yung AR, Deakin JFW, Husain N. A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol. Trials. 2017 Nov 9;18(1):524. doi: 10.1186/s13063-017-2275-y. |
| Label | URL |
|---|---|
| Website of Pakistan Institute of Learning and Living | View source |
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| Omega-3 fatty acids | Drug | Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose |
|
| Placebo | Drug | Placebo added to TAU |
|
| Minocycline Plus Omega-3 fatty acids | Drug | Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose |
|
| Karachi |
| Sindh |
| 72000 |
| Pakistan |
| Karwn e Hayat | Karachi | Sindh | 72000 | Pakistan |
| Colleges and Universities | Karachi | Sindh | Pakistan |
| Community | Karachi | Sindh | Pakistan |
| General Practitioners (GPs) | Karachi | Sindh | Pakistan |
| Institute of Behavioral Sciences | Karachi | Sindh | Pakistan |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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