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

Psychosis Clinical Trial

— NAYAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569307
• Other study ID #: PILL-NAYAB-001
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: March 2019

Study information

• Verified date: August 2019
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• At Risk Mental State (ARMS)
• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Drug:
• Minocycline
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
• Omega-3 fatty acids
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
• Placebo
Placebo added to TAU
• 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

Locations

Country	Name	City	State
Pakistan	Abasi Shaheed Hospital	Karachi	Sindh
Pakistan	Civil hospital Karachi	Karachi	Sindh
Pakistan	Colleges and Universities	Karachi	Sindh
Pakistan	Community	Karachi	Sindh
Pakistan	General Practitioners (GPs)	Karachi	Sindh
Pakistan	Institute of Behavioral Sciences	Karachi	Sindh
Pakistan	Karwn e Hayat	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transition to psychotic disorder	Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.	12 Months
Secondary	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

External Links

•   Website of Pakistan Institute of Learning and Living