NCT02533232

Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia

Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia: A Randomised Placebo-controlled Double-blind Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This a randomized double-blind placebo controlled trial which aims to determine the beneficial effects of minocycline augmentation to clozapine in partial responders to Treatment Resistant Schizophrenia (TRS).

Detailed description

The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms. The secondary objectives are to determine: * Effects on cognitive functioning. * Effects on social functioning and quality of life. * Safety and tolerability. * Possible additive effects of Minocycline added to TAU * The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo. The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder

Interventions

Type	Name	Description
DRUG	Minocycline	Minocycline 200mg per day

Timeline

• Start date: 2022-08-30
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2015-08-26
• Last updated: 2022-04-29

Locations

4 sites across 1 country: Pakistan