Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study

Shalvata Mental Health Center

Status and phase

Unknown

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Minocycline

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01133080

SHA-0008-10

Details and patient eligibility

About

Double - Blind, Randomized, single centered study. The purpose of this study is to assess the feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for positive symptoms in adults suffering from schizophrenia.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women 20-65 years of age.
Primary DSM-IV diagnosis of Schizophrenia based on SCID for schizophrenia and confirmed by two senior psychiatrists.
Patients who scored "moderate" (4) or higher on at least three of seven positive items in PANSS
Initiated on treatment with atypical anti-psychotic medication.
Capable and willing to provide informed consent
Able to adhere to the treatment schedule
Able to read, hear, write and speak the local language.
Has signed a written informed consent to participate in the study

Exclusion criteria

Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia including alcohol and drug dependence, or depression.
Current suicidal ideation or history of a suicide attempt in the past 3 years
Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse. or women who are breastfeeding
Subjects who were taking a known contraindication to minocycline treatment.
Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
Subjects who were under compulsory hospitalization.