Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial

NCT02263872 | Completed Phase 4 DMC

• 1 other identifier: MINDEP001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

In this double blind randomised controlled pilot trial the investigators aim to determine the efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive disorder. The investigators hypothesize that the multiple neuroprotective effects of minocycline will lead to an improvement in depressive symptoms in participants that were given minocycline plus treatment as usual

Conditions

Depressive Disorder; Mood Disorders; Depressive Disorder, Treatment Resistant; Antidepressive Agents

Outcome Measures

Primary Outcomes (1)

• The primary clinical outcome measures will be mean change from baseline on the Hamilton Depression Scale scores

  12 weeks

Secondary Outcomes (3)

• PHQ-9

  Baseline, Week 2, week 4, week 8, week 12

• GAD-7

  Baseline, Week 2, week 4, week 8, week 12

• CGI

  Baseline, Week 2, week 4, week 8, week 12

Study Arms (2)

Minocycline

EXPERIMENTAL

Minocycline 200mg perday

Drug: Minocycline

comparison group with placebo

PLACEBO COMPARATOR

Placebo provide

Drug: Minocycline

Interventions

Minocycline DRUG

Minocycline 200mg perday

Also known as: mesodrum

Minocycline; comparison group with placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-65 years
• Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of major depressive disorder
• competent and willing to give informed consent
• taking the current antidepressant medication for a minimum of 4 weeks prior to baseline
• the current episode of depression has failed to remit with at least two courses of antidepressant treatment (one of which is the current course)
• able to take oral medication
• if female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.

You may not qualify if:

• relevant medical illness (renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis)
• prior history of intolerance to any of the tetracyclines
• concomitant penicillin therapy
• concomitant anticoagulant therapy
• presence of a seizure disorder
• currently taking valproic acid
• any change of psychotropic medications within the previous 4 weeks
• diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-IV criteria
• pregnant or breast-feeding
• presence of primary psychotic disorder.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• King's College London: collaborator

Study Sites (3)

Abasi Shaheed Hospital

Karachi, Sindh, 72000, Pakistan

Location

Civil hospital Karachi

Karachi, Sindh, 72000, Pakistan

Location

Karwan-e-Hayat

Karachi, Sindh, Pakistan

Location

Related Publications (17)

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  BACKGROUND

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  PMID: 22423117 BACKGROUND

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  PMID: 21518864 BACKGROUND

• Soczynska JK, Mansur RB, Brietzke E, Swardfager W, Kennedy SH, Woldeyohannes HO, Powell AM, Manierka MS, McIntyre RS. Novel therapeutic targets in depression: minocycline as a candidate treatment. Behav Brain Res. 2012 Dec 1;235(2):302-17. doi: 10.1016/j.bbr.2012.07.026. Epub 2012 Aug 10.

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• Chaudhry IB, Hallak J, Husain N, Minhas F, Stirling J, Richardson P, Dursun S, Dunn G, Deakin B. Minocycline benefits negative symptoms in early schizophrenia: a randomised double-blind placebo-controlled clinical trial in patients on standard treatment. J Psychopharmacol. 2012 Sep;26(9):1185-93. doi: 10.1177/0269881112444941. Epub 2012 Apr 23.

  PMID: 22526685 BACKGROUND

• Miyaoka T, Furuya M, Yasuda H, Hayashida M, Nishida A, Inagaki T, Horiguchi J. Yi-gan san as adjunctive therapy for treatment-resistant schizophrenia: an open-label study. Clin Neuropharmacol. 2009 Jan-Feb;32(1):6-9. doi: 10.1097/WNF.0b013e31817e08c3.

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• Zazula R, Husain MI, Mohebbi M, Walker AJ, Chaudhry IB, Khoso AB, Ashton MM, Agustini B, Husain N, Deakin J, Young AH, Berk M, Kanchanatawan B, Ng CH, Maes M, Berk L, Singh AB, Malhi GS, Dean OM. Minocycline as adjunctive treatment for major depressive disorder: Pooled data from two randomized controlled trials. Aust N Z J Psychiatry. 2021 Aug;55(8):784-798. doi: 10.1177/0004867420965697. Epub 2020 Oct 22.

  PMID: 33092404 DERIVED

• Husain MI, Chaudhry IB, Husain N, Khoso AB, Rahman RR, Hamirani MM, Hodsoll J, Qurashi I, Deakin JF, Young AH. Minocycline as an adjunct for treatment-resistant depressive symptoms: A pilot randomised placebo-controlled trial. J Psychopharmacol. 2017 Sep;31(9):1166-1175. doi: 10.1177/0269881117724352. Epub 2017 Aug 31.

  PMID: 28857658 DERIVED

• Husain MI, Chaudhry IB, Rahman RR, Hamirani MM, Qurashi I, Khoso AB, Deakin JF, Husain N, Young AH. Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial. Trials. 2015 Sep 15;16:410. doi: 10.1186/s13063-015-0933-5.

  PMID: 26374703 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Mood Disorders; Depressive Disorder, Treatment-Resistant

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Dr. Muhammad Ishrat

  Institute of Psychiatry, Psychology and Neuroscience, Kings college London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: October 8, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

PA (3)