Minocycline Augmentation of Clozapine for Treatment Resis... | NCT02533232

Studies
Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia

NCT02533232

Sponsor

Pakistan Institute of Living and Learning

Status

Unknown status

Last Update Posted

Apr 29, 2022Actual

Enrollment

60Estimated

Phase

Phase 1

Conditions

Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Interventions

Minocycline

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2022Estimated

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Aug 24, 2015

First Submission Date that Met QC Criteria

Aug 25, 2015

First Posted Date

Aug 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2022

Last Update Posted Date

Apr 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	Matching placebo for Minocycline	Drug: Minocycline
Minocycline	Experimental	Minocycline 200mg once a day orally	Drug: Minocycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minocycline	Drug	Minocycline 200mg per day	Minocycline placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive and Negative Syndrome Scale PANSS	PANSS is an assessment measures to assess severity of symptoms of schizophrenia	3 months

Secondary Outcomes

Measure	Description	Time Frame
CogState	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.	3 Month

Other Outcomes

Measure	Description	Time Frame
Social Functioning Scale	Self-rating questionnaire assessing social functioning in 7 domains.	3 Month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr.Inti Qurashi, MD	Contact			Inti.Qurashi@merseycare.nhs.uk
Prof.Imran B Chaudhry, MD	Contact	02135871845		ibchaudhry@btinternet.com

Overall Officials

Name	Affiliation	Role
Dr.Inti Qurashi, MD	Manchester University ,UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abasi Shaheed Hospital	Recruiting	Karachi	Sindh	72000	Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24646811	Background	Qurashi I, Collins JD, Chaudhry IB, Husain N. Promising use of minocycline augmentation with clozapine in treatment-resistant schizophrenia. J Psychopharmacol. 2014 Jul;28(7):707-8. doi: 10.1177/0269881114527358. Epub 2014 Mar 19.
9366002	Background	Conley RR, Buchanan RW. Evaluation of treatment-resistant schizophrenia. Schizophr Bull. 1997;23(4):663-74. doi: 10.1093/schbul/23.4.663.

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
C562573	cyclopia sequence
D001523	Mental Disorders

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic