Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Schizophrenia is a devastating and costly illness. One-third to one-half of people with
      schizophrenia do not respond to the most current drugs leaving clozapine as the best
      alternative for treatment. However, over 60% of people treated with clozapine continue to
      have persistent symptoms and cognitive impairments. Little data is available to support
      evidence-based recommendations to guide clinicians in treating these patients. Preliminary
      data has suggested that adjunct treatment with minocycline may offer robust symptom
      improvement in patients with schizophrenia, including those taking clozapine. Minocycline has
      had interesting effects; including suggesting it may have a significant role in treatment of
      neurologic and psychiatric disorders. Minocycline is currently available generically; its
      side effects are well-described and minimal. The proposed double-blind treatment study seeks
      to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent
      positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology.
      This knowledge could lead to the more effective treatment of patients with schizophrenia. The
      research itself may lead to a better understanding of the pathophysiology of positive
      symptoms and cognitive impairments, which could contribute to improved treatments in the
      future.
    


Intervention name(s): Minocycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition.; Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition.
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Symptoms; Clozapine