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Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia

Sponsor
Pakistan Institute of Living and Learning (Other)
Overall Status
Recruiting
CT.gov ID
NCT02533232
Collaborator
(none)
60
Enrollment
4
Locations
2
Arms
4
Anticipated Duration (Months)
15
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This a randomized double-blind placebo controlled trial which aims to determine the beneficial effects of minocycline augmentation to clozapine in partial responders to Treatment Resistant Schizophrenia (TRS).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms.

The secondary objectives are to determine:

  • Effects on cognitive functioning.

  • Effects on social functioning and quality of life.

  • Safety and tolerability.

  • Possible additive effects of Minocycline added to TAU

  • The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo.

The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia: A Randomised Placebo-controlled Double-blind Trial
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

Matching placebo for Minocycline

Drug: Minocycline
Minocycline 200mg per day
Other Names:
  • Mesodrum

    		•
    Experimental: Minocycline

    Minocycline 200mg once a day orally

    Drug: Minocycline
    Minocycline 200mg per day
    Other Names:
  • Mesodrum

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Positive and Negative Syndrome Scale PANSS [3 months]

      PANSS is an assessment measures to assess severity of symptoms of schizophrenia

    Secondary Outcome Measures

    1. CogState [3 Month]

      Measuring all seven domains recommended by MATRICS (NIMH initiative). These domains include speed processing, attention/vigilance, Working memory (nonverbal & verbal), verbal learning, visual learning, reasoning and problem solving and social cognition's.

    Other Outcome Measures

    1. Social Functioning Scale [3 Month]

      Self-rating questionnaire assessing social functioning in 7 domains.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female patients aged between 18-65 years, IQ >70 (to complete assessments) identified by treating psychiatrist.

    • Confirmation of schizophrenia by using The MINI psychiatric interview (at baseline only)

    • Assessed as competent to provide informed consent by treating psychiatrist.

    • Antipsychotic medication has remained stable 4 weeks prior to baseline *. Assessed as a partial responder to clozapine: patients prescribed clozapine at a stable therapeutic dose for a minimum of 3 months with total Positive and Negative Syndrome Schizophrenia (PANSS) score >70.

    Exclusion Criteria:

    • Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the Tetracyclines.

    • Concomitant Penicillin therapy or concomitant anticoagulant therapy.

    • Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to ICD 10 criteria.

    • Treatment with Warfarin or Lamotrigine.

    • Current or previous treatment with minocycline or other tetracycline antibiotics in the preceding three months before study entry.

    • Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.

    • Pregnant or breast-feeding females

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abasi Shaheed Hospital Karachi Sindh Pakistan 72000
    2 Civil hospital Karachi Karachi Sindh Pakistan 72000
    3 Karwn e Hayat Karachi Sindh Pakistan 72000
    4 Institute of Behavioral Sciences Karachi Sindh Pakistan

    Sponsors and Collaborators

    • Pakistan Institute of Living and Learning

    Investigators

    • Principal Investigator: Dr.Inti Qurashi, MD, Manchester University ,UK

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Pakistan Institute of Living and Learning
    ClinicalTrials.gov Identifier:
    NCT02533232
    Other Study ID Numbers:
    • PILL-MAC-001
    First Posted:
    Aug 26, 2015
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pakistan Institute of Living and Learning
    Schizophrenia
    Anti-inflammatory
    Clozapine
    Minocycline
    Psychosis NOS
    Additional relevant MeSH terms:
    Disease
    Schizophrenia
    Psychotic Disorders
    Minocycline

    Study Results

    No Results Posted as of Apr 29, 2022