Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients
Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Minocycline (Drug); Placebo (Drug)
Sponsored by: University of Maryland
Official(s) and/or principal investigator(s):
Deanna Kelly, Pharm.D., BCPP, Principal Investigator, Affiliation: University of Maryland
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.
Official title: Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The efficacy of minocycline compared to placebo to improve positive Psychotic Symptoms
The efficacy of minocycline compared to placebo to improve cognitive symptoms
The efficacy of minocycline compared to placebo to improve negative symptoms.
The effect of minocycline on inflammatory biomarkers associated with schizophrenia.
The safety of adjunct minocycline compared to placebo as defined by reported side effects, laboratory findings and extrapyramidal symptoms.
The efficacy of adjunct minocycline to placebo to improve depressive symptoms
The effect of adjunct minocycline to placebo on global clinical improvement of symptoms.
The efficacy of adjunct minocycline compared to placebo on perceived health quality and general well being.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- History of organic brain disease
- DSM-IV diagnosis of Mental Retardation
- DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months
- DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except
- 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
Locations and Contacts
Maryland Psychiatric Research Center, Catonsville, Maryland 21228, United States
Starting date: July 2011
Last updated: January 27, 2014