Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Clozapine; Minocycline

Criteria

Inclusion Criteria:

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder

• Male or Female

• Age: 18 to 65 years

• Caucasian or Non-Caucasian

• At least six months of clozapine treatment

• Clozapine treatment for incomplete symptoms response (evidence of two failed previous trials of antipsychotics)

• Current dose of 200 mg/day for at least 3 months AND a documented clozapine blood level 350 ng/ml prior to study start (maximum clozapine dose of 900 mg/day)

• BPRS total score of 45 or more on the 18 item version (scale: 1-7)

• BPRS positive symptom item total score of 8 or more

• BPRS positive symptom score of 4 or greater on at least one item

Exclusion Criteria:

• History of organic brain disease

• DSM-IV diagnosis of Mental Retardation

• DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)

• DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine)

• Pregnancy or lactation

• Significant renal or liver impairment

• Previous known hypersensitivity to tetracyclines

• Current treatment with tetracycline or derivative

• Current treatment with lamotrigine

• Treatment with oral contraceptives

• Current known infection

• Treatment with cholestyramine or colestipol

• Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)

• Treatment with warfarin

• Abnormal (considered positive) Lyme titer