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

Last updated: September 19, 2016
Sponsor: Beer Yaakov – Ness Ziona Mental Health Center
Overall Status: Trial Status Unknown

Phase

3

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT02907437
519
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women 18-60 years of age.

  2. Diagnostic and Statistical Manual (DSM) 5 diagnosis of Schizophrenia/ Schizo effectivedisorder based on the Structured Clinical Interview for the Diagnostic and StatisticalManual for Mental Disorders (SCID) for schizophrenia and confirmed by two seniorpsychiatrists.

  3. Initiated on treatment with stable dosage (within +/- 25%) of atypical anti-psychoticmedication 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

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 medicallyaccepted form of contraception .(if using oral contraceptives, during the Minocyclinetreatment, subject should use an additional contraceptives), or women who arebreastfeeding.

  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 thepreceding 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 Design

Total Participants: 40
Study Start date:
January 01, 2015
Estimated Completion Date:
January 31, 2018

Connect with a study center

  • Bees Yaakov and Ness Ziona Mental Health Center

    Beer Yaakov,
    Israel

    Active - Recruiting

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