Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGMinocycline
minocycline 200 mg/day orally in two divided doses for the second week. From weeks 3 to weeks 5, minocycline 400 mg/day orally in two divided doses.
DRUGplacebo
placebo 200 mg/day orally in two divided doses for the first week. placebo 200 mg/day orally in two divided doses for the second week. From weeks 3 to weeks 5, placebo 400 mg/day orally in two divided doses.
Sponsors
Shalvata Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive symptoms | from baseline to the end of the study (day 56) | Positive symptoms: The change in Scale for the Positive and Negative Syndrome Scale (PANSS) score from baseline to the end of the study and the change in Clinical Global Impression Scale (CGI). |
Countries
Israel
Contacts
Primary Contactyechiel levkovitz, MD, PhD
Outcome results
None listed