Minocycline Augmentation to Clozapine (NCT02124811) | Clinical Trial Compass
CompletedPhase 4
Minocycline Augmentation to Clozapine
United States10 participantsStarted 2015-02
Plain-language summary
The proposed pilot study will compare minocycline augmentation with clozapine in individuals with high vs low inflammation as measured by CRP. Investigators hypothesize that minocycline will be well tolerated and will result in an improvement in the symptoms of schizophrenia, cognition, as well as improve the quality of life for patients preferentially in patients with high CRPs. Investigators plan to use a variety of different scales to measure improvement in the varying symptoms of schizophrenia as well as cognitive function, which will be administered to patients at three week intervals for a total study time of twelve weeks. Investigators hypothesize that minocycline could prove to be an effective, well tolerated, and inexpensive medication for treatment resistant patients with schizophrenia whom have particular difficulties with social interactions, obtaining and maintaining employment, and overall quality of life. Furthermore, investigators hypothesize that the data obtained in this study will contribute to the ongoing exploration of the role of inflammation in the brain of patients with schizophrenia and help understand and target the role of various inflammatory markers in the pathophysiology and treatment of treatment resistant schizophrenia.
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:
* Mini International Neuropsychiatric Interview 6.0 diagnosis of schizophrenia or schizoaffective disorder
* Persistent symptoms of schizophrenia as measured by one of the following PANSS items: Total score ≥60, negative subscale ≥ 15, positive subscale ≥ 15, general psychopathology subscale ≥ 30
* Currently taking clozapine and the dose has been adjusted within 100 mg of study enrollment
* Currently taking clozapine for 3 months and documented clozapine level ≥ 350 ng/ml prior to study start
* No other psychotropic medication changes for one month prior to study enrollment
* No new psychosocial interventions for one month prior to study enrollment
* No prior experience on minocycline for greater than 1 week
* May be taking any other psychotropic, dermatologic, or gastrointestinal drugs
Exclusion Criteria:
* History of organic brain disease
* Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-TR diagnosis of Mental Retardation or Dementia
* DSM-IV-TR diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
* Pregnancy or lactation
* Known hypersensitivity to tetracyclines
* Current known infection
* Any known neurological disease or medical condition that could impact the measurement of the constructs being assessed
* Inpatient psychiatric hospitalization for worsening of psychiatric symptoms, OR worsening of symptoms requiring a new level of outpatient support, OR started on a new anti-inflammatory medicatio…
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.
What they're measuring
1
Positive Subscale Score of the Positive and Negative Syndrome Scale (PANSS)
Timeframe: Baseline, Week 12
2
Negative Subscale Score of the Positive and Negative Syndrome Scale (PANSS)
Timeframe: Baseline, Week 12
3
Brief Assessment of Cognition in Schizophrenia (BACS) Score
Timeframe: Baseline, Week 12
4
General Psychopathology Score of the Positive and Negative Syndrome Scale (PANSS)