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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01133080
• Other study ID #: SHA-0008-10
• Status: Recruiting
• Phase: Phase 4
• First received: May 26, 2010
• Last updated: January 4, 2012
• Start date: June 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: yechiel levkovitz, MD, PhD
• Phone: 972-9-7478644
• Email: levkovit[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 ß-lactam antibiotics in the preceding half year before study entry.

• Subjects who were under compulsory hospitalization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center	Hod Hasharon
Israel	shalvata MHC	Hod HAsharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No