Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male and female patients aged between 18-65 years, IQ >70 (to complete assessments) identified by treating psychiatrist.

• Confirmation of schizophrenia by using The MINI psychiatric interview (at baseline only)

• Assessed as competent to provide informed consent by treating psychiatrist.

• Antipsychotic medication has remained stable 4 weeks prior to baseline *. Assessed as a partial responder to clozapine: patients prescribed clozapine at a stable therapeutic dose for a minimum of 3 months with total Positive and Negative Syndrome Schizophrenia (PANSS) score >70.

Exclusion Criteria:

• Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the Tetracyclines.

• Concomitant Penicillin therapy or concomitant anticoagulant therapy.

• Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to ICD 10 criteria.

• Treatment with Warfarin or Lamotrigine.

• Current or previous treatment with minocycline or other tetracycline antibiotics in the preceding three months before study entry.

• 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 breast-feeding females