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

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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:

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pakistan Institute of Learning and Living; Pakistan Institute of Living and Learning
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. Male and female help seeking individuals aged between 16-35 years.

2. Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).

3. Assessed as competent to provide informed consent.

Exclusion Criteria:

1. History ofpreviously experiencing a psychotic illness (treated or untreated).

2. IQ < 70 and/or history of learning disability.

3. Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.

4. Organic brain disease e.g. epilepsy.

5. treatment with an antipsychotic or mood-stabilising agent.

6. Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.

7. Concomitant penicillin therapy or concomitant anticoagulant therapy.

8. Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.

9. Treatment with warfarin or lamotrigine.

10. Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.

11. Current treatment with any anti-inflammatory medication.

12. Treatment with electroconvulsive therapy within the 12 weeks preceding the study.

13. Active expression of suicidal ideation (CAARMS item 7.3 severity score 6) or current aggression/dangerous behaviour (CAARMS item 5.4 severity score 6). 14. Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.

15. Pregnant or breastfeeding females.