Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia (NCT02533232) | Clinical Trial Compass
UnknownPhase 1
Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia
Pakistan60 participantsStarted 2022-08-30
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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