NCT02569307 (NAYAB) is a Phase 2 clinical trial of Minocycline in At Risk Mental State (ARMS), sponsored by Pakistan Institute of Living and Learning.

Who is sponsoring NCT02569307?

NCT02569307 is sponsored by Pakistan Institute of Living and Learning.

What drugs are being tested in NCT02569307?

Interventions in NCT02569307: Minocycline, Omega-3 fatty acids, Placebo, Minocycline Plus Omega-3 fatty acids.

What condition does NCT02569307 study?

NCT02569307 studies At Risk Mental State (ARMS), Psychosis.

Is NCT02569307 still recruiting?

NCT02569307 is currently completed. Last updated 2 August 2019.

Last reviewed 2019-08-02 · How we verify

NCT02569307: NAYAB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 2 August 2019

What this trial tests

Phase 2 trial testing Minocycline in At Risk Mental State (ARMS) in 326 participants. Completed in 1 March 2019.

Timeline

1 October 2015

Primary endpoint
1 December 2018

1 March 2019

Quick facts

Lead sponsor	Pakistan Institute of Living and Learning
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	treatment
Enrollment	326
Start date	1 October 2015
Primary completion	1 December 2018
Estimated completion	1 March 2019
Sites	7 locations across Pakistan

Drugs / interventions tested

Minocycline (MINOCYCLINE) — full drug profile →
Omega-3 fatty acids — full drug profile →
Placebo
Minocycline Plus Omega-3 fatty acids — full drug profile →

Conditions studied

At Risk Mental State (ARMS) — all drugs for At Risk Mental State (ARMS) →
Psychosis — all drugs for Psychosis →

Sponsor

Pakistan Institute of Living and Learning

Who can join

Adults 16 to 35, any sex, with At Risk Mental State (ARMS) or Psychosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Transition to psychotic disorder
Time frame: 12 Months
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.

Sponsor's own description

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:

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Preventive Treatments for Psychosis: Umbrella Review (Just the Evidence).
Fusar-Poli P, Davies C, Solmi M, Brondino N, et al · · 2019 · cited 84× · PMID 31920732 · DOI 10.3389/fpsyt.2019.00764
Interventions for prodromal stage of psychosis.
Bosnjak Kuharic D, Kekin I, Hew J, Rojnic Kuzman M, et al · · 2019 · cited 51× · PMID 31689359 · DOI 10.1002/14651858.cd012236.pub2
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.
Qurashi I, Chaudhry IB, Khoso AB, Farooque S, et al · · 2017 · cited 12× · PMID 29121974 · DOI 10.1186/s13063-017-2275-y
Is it possible to prevent excessive synaptic pruning in schizophrenia? Possibilities and limitations.
Pawlak A, Stefanowicz J, Kotkowska Z, Gabryelska A, et al · · 2025 · PMID 41169352 · DOI 10.3389/fnsyn.2025.1656232

Verify or expand the search:

Other trials of Minocycline

Trials testing the same drug.

NCT05605366 — Minocycline In Neurocognitive Outcomes - Sickle Cell Disease · Phase 1 · not yet recruiting
NCT07305896 — Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage · NA · not yet recruiting
NCT07068607 — Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradicatio · Phase 4 · recruiting
NCT06523764 — Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment · Phase 4 · active not recruiting
NCT06120140 — Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small · Phase 2 · recruiting

Other Pakistan Institute of Living and Learning trials

Trials by the same sponsor.

NCT07015944 — Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan · NA · recruiting
NCT06442007 — Universally Delivered Interventions for Young People · NA · not yet recruiting
NCT07188597 — Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis · NA · recruiting
NCT03974620 — Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia · NA · not yet recruiting
NCT05933850 — Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02569307 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pakistan Institute of Living and Learning
Last refreshed: 2 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02569307.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing