Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

September 19, 2016 updated by: Dr. Stryjer Rafael (MD), Beer Yaakov - Ness Ziona Mental Health Center

Minocycline add-on Medication to Antipsychotics in the Treatment of Schizophrenia Patients: A Double- Blind Randomized Controlled Trial

Current medications have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. In the past years, various findings from clinical studies showed its potential role for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating positive, negative and cognitive symptoms in schizophrenia patients.The current study is a single center, double-blind, randomized study that assess the adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in adult patients suffering from schizophrenia. Patients will be recruited and randomly allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In addition, all patients will receive probiotics (450mg/day) in order to prevent any gastrointestinal influences of antibiotics administration. Positive and negative symptoms , as well as cognitive functions will be assessed before and after treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women 18-60 years of age.
  2. Diagnostic and Statistical Manual (DSM) 5 diagnosis of Schizophrenia/ Schizo effective disorder based on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) for schizophrenia and confirmed by two senior psychiatrists.
  3. Initiated on treatment with stable dosage (within +/- 25%) of atypical anti-psychotic medication for at least 6 weeks.
  4. Capable and willing to provide informed consent.
  5. Able to adhere to the treatment schedule.
  6. Able to read, hear, write and speak the local language.
  7. Has signed a written informed consent to participate in the study.

Exclusion Criteria:

  1. Patients with acute, unstable, or decompensated medical condition.
  2. Present substance abuse.
  3. Major depression (MDD) diagnosis.
  4. Attention deficit/ hyperactivity disorder (ADHD/ADD) diagnosis.
  5. Cognitive dysfunction, such as Alzheimer disease or retardation.
  6. Acute psychotic state.
  7. Aggressive or violent patient or with vast history of aggressive or violent behavior.
  8. Diagnosis of Borderline/ Anti Social/ Narcissistic personality disorders.
  9. Previous sensitivity to Minocycline.
  10. Current suicidal ideation or history of a suicide attempt in the past three years
  11. Known or suspected pregnancy or women of childbearing potential not using a medically accepted form of contraception .(if using oral contraceptives, during the Minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding.
  12. Subjects who are taking a known contraindication to Minocycline treatment (anti-coagulants, other antibiotics (of the penicillin group), methoxyflurane, Isotretinoin).
  13. Subjects who had received treatment with Minocycline or β-lactam antibiotics in the preceding half year before study entry.
  14. Subjects who are under compulsory hospitalization.
  15. Subjects with medical history of Intestinal disease, Peptic ulcer or gastritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Minocycline treatment
Intervention: Drug: Minocycline (200 mg/day)
Drug: Minocycline
Minocycline as an add-on drug (200 mg/day)
Other: Probiotics
(450 mg/day)
Placebo Comparator: Placebo treatment
Placebo Intervention: Drug: Placebo (200 mg/day)
Other: Probiotics
(450 mg/day)
Drug: Placebo
(200 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Syndrome Scale (PANSS)
Time Frame: Change in PANSS scores over the 6-weeks study
Change in PANSS scores over the 6-weeks study
Scale for Assessment of Negative Symptoms (SANS)
Time Frame: Change in SANS scores over the 6-weeks study
Change in SANS scores over the 6-weeks study

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impressions (CGI)
Time Frame: Change in CGI scores over the 6-weeks study
Change in CGI scores over the 6-weeks study
The Montreal Cognitive Assessment (MoCa) task
Time Frame: Change in MoCa scores over the 6-weeks study
Change in MoCa scores over the 6-weeks study
Trail making task (TMT)
Time Frame: Change in TMT scores over the 6-weeks study
Change in TMT scores over the 6-weeks study
Empathy Cartoon task
Time Frame: Change in Empathy Cartoon task scores over the 6-weeks study
Change in Empathy Cartoon task scores over the 6-weeks study
Interpersonal Reactivity Index (IRI) Questionnaire
Time Frame: Change in IRI scores over the 6-weeks study
Change in IRI scores over the 6-weeks study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beer Yaakov - Ness Ziona Mental Health Center

Collaborators

Bar-Ilan University, Israel

Investigators

  • Principal Investigator: Rafael Stryjer, MD, Beer Yaakov - Ness Ziona Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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