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Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients

Information source: University of Maryland
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Minocycline (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Deanna Kelly, Pharm.D., BCPP, Principal Investigator, Affiliation: University of Maryland

Overall contact:
Ann Kearns, B.S, Phone: 410-402-6854, Email: akearns@mprc.umaryland.edu

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.

Clinical Details

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

Primary outcome:

The efficacy of minocycline compared to placebo to improve positive Psychotic Symptoms

The efficacy of minocycline compared to placebo to improve cognitive symptoms

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Ann Kearns, B.S, Phone: 410-402-6854, Email: akearns@mprc.umaryland.edu

Maryland Psychiatric Research Center, Catonsville, Maryland 21228, United States; Recruiting
Ann Kearns, BS, Phone: 410-402-6854, Email: akearns@mprc.umaryland.edu
Stephanie Feldman, LCSW, Phone: 410-402-6885, Email: sfeldman@mprc.umaryland.edu
Deanna L. Kelly, Pharm.D., BCPP, Principal Investigator
Additional Information

Starting date: July 2011
Last updated: October 11, 2012

Page last updated: February 07, 2013

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