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

NCT01133080 | Unknown Phase 4 DMC

• 1 other identifier: SHA-0008-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive symptoms

  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).

  from baseline to the end of the study (day 56)

Study Arms (2)

Minocycline

EXPERIMENTAL

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Minocycline 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.

Minocycline

placebo 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.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (2)

Shalvata Mental Health Center

Hod HaSharon, Israel

RECRUITING

shalvata MHC

Hod HaSharon, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Yechiel Levkovitz, MD, PhD

  Shalvata MHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yechiel levkovitz, MD, PhD

CONTACT

972-9-7478644; levkovit@netvision.net.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

IL (2)