Status:
COMPLETED
Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01433055
Start Date
July 1 2011
End Date
January 1 2014
Last Update
August 28 2019
Active Locations (1)
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1
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228