Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    60
  • sponsor
    Pakistan Institute of Living and Learning
Updated on 9 May 2022
antipsychotics
clozapine
schizophrenia

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).

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.

Details
Condition Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Treatment Minocycline
Clinical Study IdentifierNCT02533232
SponsorPakistan Institute of Living and Learning
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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