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

NCT02569307 | Completed Phase 2 DMC

• 1 other identifier: PILL-NAYAB-001
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 7

Brief 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:

Conditions

At Risk Mental State (ARMS); Psychosis

Keywords

At Risk of Mental State; Prodromal Phase; Psychosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measured severity ofAt Risk of Mental State ( ARMS) symptoms

  12 Months

Study Arms (4)

Minocycline

ACTIVE COMPARATOR

Minocycline added to TAU Minocycline will be administered in 200mg once daily dose

Drug: Minocycline

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

Drug: Omega-3 fatty acids

Placebo

ACTIVE COMPARATOR

Placebo added to TAU

Drug: Placebo

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

Drug: Minocycline Plus Omega-3 fatty acids

Interventions

Minocycline DRUG

Minocycline added to TAU Minocycline will be administered in 200mg once daily dose

Minocycline

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

Omega-3 fatty acids

Placebo DRUG

Placebo added to TAU

Placebo

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

Minocycline Plus Omega-3 fatty acids

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female help seeking individuals aged between 16-35 years.
• Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).
• Assessed as competent to provide informed consent.

You may not qualify if:

• History ofpreviously experiencing a psychotic illness (treated or untreated).
• IQ \< 70 and/or history of learning disability.
• Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.
• Organic brain disease e.g. epilepsy.
• treatment with an antipsychotic or mood-stabilising agent.
• Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.
• Concomitant penicillin therapy or concomitant anticoagulant therapy.
• Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
• Treatment with warfarin or lamotrigine.
• Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.
• Current treatment with any anti-inflammatory medication.
• Treatment with electroconvulsive therapy within the 12 weeks preceding the study.
• 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.
• \. Pregnant or breastfeeding females.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (7)

Abasi Shaheed Hospital

Karachi, Sindh, 72000, Pakistan

Location

Civil hospital Karachi

Karachi, Sindh, 72000, Pakistan

Location

Karwn e Hayat

Karachi, Sindh, 72000, Pakistan

Location

Colleges and Universities

Karachi, Sindh, Pakistan

Location

Community

Karachi, Sindh, Pakistan

Location

General Practitioners (GPs)

Karachi, Sindh, Pakistan

Location

Institute of Behavioral Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 29121974 DERIVED

Related Links

• Website of Pakistan Institute of Learning and Living

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Minocycline; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Dr.Inti Qurashi, MD

  Manchester University ,UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2015
• First Posted: October 6, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

PA (7)