Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia
1 other identifier
interventional
60
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 schizophrenia
Started Aug 2022
Shorter than P25 for phase_1 schizophrenia
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedStudy Start
First participant enrolled
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedApril 29, 2022
April 1, 2022
4 months
August 24, 2015
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive and Negative Syndrome Scale PANSS
PANSS is an assessment measures to assess severity of symptoms of schizophrenia
3 months
Secondary Outcomes (1)
CogState
3 Month
Other Outcomes (1)
Social Functioning Scale
3 Month
Study Arms (2)
placebo
PLACEBO COMPARATORMatching placebo for Minocycline
Minocycline
EXPERIMENTALMinocycline 200mg once a day orally
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Abasi Shaheed Hospital
Karachi, Sindh, 72000, Pakistan
Civil hospital Karachi
Karachi, Sindh, 72000, Pakistan
Karwn e Hayat
Karachi, Sindh, 72000, Pakistan
Institute of Behavioral Sciences
Karachi, Sindh, Pakistan
Related Publications (15)
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.
PMID: 24646811BACKGROUNDConley RR, Buchanan RW. Evaluation of treatment-resistant schizophrenia. Schizophr Bull. 1997;23(4):663-74. doi: 10.1093/schbul/23.4.663.
PMID: 9366002BACKGROUNDChakos M, Lieberman J, Hoffman E, Bradford D, Sheitman B. Effectiveness of second-generation antipsychotics in patients with treatment-resistant schizophrenia: a review and meta-analysis of randomized trials. Am J Psychiatry. 2001 Apr;158(4):518-26. doi: 10.1176/appi.ajp.158.4.518.
PMID: 11282684BACKGROUNDRossler W, Salize HJ, van Os J, Riecher-Rossler A. Size of burden of schizophrenia and psychotic disorders. Eur Neuropsychopharmacol. 2005 Aug;15(4):399-409. doi: 10.1016/j.euroneuro.2005.04.009.
PMID: 15925493BACKGROUNDSommer IE, Begemann MJ, Temmerman A, Leucht S. Pharmacological augmentation strategies for schizophrenia patients with insufficient response to clozapine: a quantitative literature review. Schizophr Bull. 2012 Sep;38(5):1003-11. doi: 10.1093/schbul/sbr004. Epub 2011 Mar 21.
PMID: 21422107BACKGROUNDLin A, Kenis G, Bignotti S, Tura GJ, De Jong R, Bosmans E, Pioli R, Altamura C, Scharpe S, Maes M. The inflammatory response system in treatment-resistant schizophrenia: increased serum interleukin-6. Schizophr Res. 1998 Jun 22;32(1):9-15. doi: 10.1016/s0920-9964(98)00034-6.
PMID: 9690329BACKGROUNDvan Berckel BN, Bossong MG, Boellaard R, Kloet R, Schuitemaker A, Caspers E, Luurtsema G, Windhorst AD, Cahn W, Lammertsma AA, Kahn RS. Microglia activation in recent-onset schizophrenia: a quantitative (R)-[11C]PK11195 positron emission tomography study. Biol Psychiatry. 2008 Nov 1;64(9):820-2. doi: 10.1016/j.biopsych.2008.04.025. Epub 2008 Jun 4.
PMID: 18534557BACKGROUNDFarber NB. The NMDA receptor hypofunction model of psychosis. Ann N Y Acad Sci. 2003 Nov;1003:119-30. doi: 10.1196/annals.1300.008.
PMID: 14684440BACKGROUNDJavitt DC, Zukin SR. Recent advances in the phencyclidine model of schizophrenia. Am J Psychiatry. 1991 Oct;148(10):1301-8. doi: 10.1176/ajp.148.10.1301.
PMID: 1654746BACKGROUNDLabrie V, Roder JC. The involvement of the NMDA receptor D-serine/glycine site in the pathophysiology and treatment of schizophrenia. Neurosci Biobehav Rev. 2010 Mar;34(3):351-72. doi: 10.1016/j.neubiorev.2009.08.002. Epub 2009 Aug 18.
PMID: 19695284BACKGROUNDAnticevic A, Gancsos M, Murray JD, Repovs G, Driesen NR, Ennis DJ, Niciu MJ, Morgan PT, Surti TS, Bloch MH, Ramani R, Smith MA, Wang XJ, Krystal JH, Corlett PR. NMDA receptor function in large-scale anticorrelated neural systems with implications for cognition and schizophrenia. Proc Natl Acad Sci U S A. 2012 Oct 9;109(41):16720-5. doi: 10.1073/pnas.1208494109. Epub 2012 Sep 25.
PMID: 23012427BACKGROUNDDeakin JF, Lees J, McKie S, Hallak JE, Williams SR, Dursun SM. Glutamate and the neural basis of the subjective effects of ketamine: a pharmaco-magnetic resonance imaging study. Arch Gen Psychiatry. 2008 Feb;65(2):154-64. doi: 10.1001/archgenpsychiatry.2007.37.
PMID: 18250253BACKGROUNDMeltzer HY. Treatment-resistant schizophrenia--the role of clozapine. Curr Med Res Opin. 1997;14(1):1-20. doi: 10.1185/03007999709113338.
PMID: 9524789BACKGROUNDDomercq M, Matute C. Neuroprotection by tetracyclines. Trends Pharmacol Sci. 2004 Dec;25(12):609-12. doi: 10.1016/j.tips.2004.10.001.
PMID: 15530637BACKGROUNDTikka T, Fiebich BL, Goldsteins G, Keinanen R, Koistinaho J. Minocycline, a tetracycline derivative, is neuroprotective against excitotoxicity by inhibiting activation and proliferation of microglia. J Neurosci. 2001 Apr 15;21(8):2580-8. doi: 10.1523/JNEUROSCI.21-08-02580.2001.
PMID: 11306611BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr.Inti Qurashi, MD
Manchester University ,UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2015
First Posted
August 26, 2015
Study Start
August 30, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
April 29, 2022
Record last verified: 2022-04