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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.