Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study
NCT ID: NCT01133080
Last Updated: 2012-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2010-06-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Minocycline
Minocycline
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.
Placebo
placebo
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.
Interventions
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Minocycline
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.
placebo
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Shalvata Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Yechiel Levkovitz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shalvata MHC
Locations
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Shalvata Mental Health Center
Hod HaSharon, , Israel
shalvata MHC
Hod HaSharon, , Israel
Countries
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Central Contacts
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Facility Contacts
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yechiel levkovitz
Role: primary
Other Identifiers
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SHA-0008-10
Identifier Type: -
Identifier Source: org_study_id
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