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

NCT ID: NCT01133080

Last Updated: 2012-01-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Minocycline

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

shalvata MHC

Hod HaSharon, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Central Contacts

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yechiel levkovitz, MD, PhD

Role: CONTACT

972-9-7478644

Facility Contacts

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Hilik Levkovitz, prof.

Role: primary

972-9-7478644

yechiel levkovitz

Role: primary

972-9-7478644

Other Identifiers

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SHA-0008-10

Identifier Type: -

Identifier Source: org_study_id

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