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A Pilot Study of Minocycline Augmentation to Clozapine in Individuals with Treatment Resistant Schizophrenia

Principal Investigator: Robert O. Cotes, MD

Co-Investigators: David R. Goldsmith, MD, Sarah Kopelovich, PhD

Population:  Men and women 18-65 years old suffering from persistent psychotic symptoms of schizophrenia taking clozapine 200mg or more daily are eligible. Patients with a history of organic brain disease, mental retardation, dementia, diagnosis of alcohol or substance dependence or abuse within the preceding six months (except nicotine), currently pregnant or breastfeeding, or have a known allergy to tetracyclines are not eligible.

Summary:  This 15 week pilot study will compare the effect of minocycline on improvement in symptoms and quality of life in patients taking clozapine for schizophrenia. All participants will receive minocycline. Participants will undergo a total of five study visits at three week intervals. At the first study visit participants will meet with Dr. Kopelovich and undergo psychological testing. On the second study visit participants will undergo laboratory testing (clozapine level, liver function tests, a comprehensive metabolic panel, hsCRP, and cytokine levels), additional psychological testing, and will begin daily augmentation therapy with minocycline. At subsequent study visits participants will again undergo psychological testing. At the final study visit participants will undergo laboratory testing (clozapine level, liver function tests, a comprehensive metabolic panel, hsCRP, and cytokine levels) as well as psychological testing.

Procedure: General screening process, weekly monitoring by psychiatrist for side effects, psychological testing (MINI, PANSS, SANS, BACS, SUMD, WHODAS 2.0, QLS, GGI, Q-LES-Q-SF, SAS, GASS, AIMS), blood draw testing (clozapine level, liver function tests, a comprehensive metabolic panel, hsCRP, and cytokine levels), treatment with FDA-approved antibiotic.

Compensation: $20 for screening visit, $10 for the first and second study visit, $5 for the third through fifth study visit, and $15 for final study visit. If completed, the study compensates $70 total.  

Contact: Rob Cotes, MD

Phone: 404-616-4752

Email: robert.o.cotes@emory.edu

Patients can go to:

www.clinicaltrials.gov