Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression

NCT01403662 | Completed Phase 3

• 1 other identifier: 3420337
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Long-term studies have emphasized that depressive symptoms and episodes account for majority of the illness burden experienced by individuals with bipolar disorder (BD). Previous studies have shown that blood levels of proteins called pro-inflammatory cytokines are abnormal in individuals with bipolar depression. The investigators hypothesize that preventing the production or release of pro-inflammatory cytokines will result in improvement of depressive symptoms in individuals with bipolar depression. Minocycline is a medication that inhibits the activation of immune cells (i.e. microglia) in the brain and reduces the production of pro-inflammatory cytokines. Treatment with minocycline has been shown to have antidepressant-like effects in animal studies and improve symptoms of individuals with schizophrenia. In this study, minocycline (100 mg twice a day) will be administered for 8 weeks to determine if it is an efficacious antidepressant for individuals with bipolar depression.

Conditions

Bipolar Disorder; Bipolar Depression; Bipolar I Depression; Bipolar II Depression

Keywords

bipolar disorder; depression; major depression; bipolar I depression; bipolar II depression; bipolar I disorder; bipolar II disorder; minocycline; minocin

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 8 on the Montgomery Asberg Depression Rating Scale (MADRS)

  The MADRS assesses depressive symptoms

  Baseline, Week 1, 2, 4, 6, 8

Secondary Outcomes (7)

• Change from baseline to week 8 on the Hamilton Depression Rating Scale 17-item (HAMD-17)

  Baseline, Week 1, 2, 4, 6, 8

• Change from baseline to week 8 on the Somatic Symptom Inventory (SSI)

  Baseline, Week 8

• Change from baseline to week 8 on the Clinical Global Impression (CGI) Rating Scale

  Baseline, Week 1, 2, 4, 6, 8

• Change from baseline to week 8 in the in neurocognitive function

  Baseline, Week 8

• Monitoring of Side-effects from baseline to week 8 with the Toronto Side Effect Scale (TSES)

  Week 1, 2, 4, 6, 8

Study Arms (1)

Minocycline

EXPERIMENTAL

Drug: Minocycline

Interventions

Minocycline DRUG

Minocycline (100 mg bid) will be administered as an adjunctive agent to conventional Health Canada-approved, or first-line CANMAT bipolar guideline-recommended, agents for bipolar disorder.

Also known as: Minocin

Minocycline

Eligibility Criteria

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

You may qualify if:

• Diagnosis of bipolar I or II disorder
• Meets criteria for a current major depressive episode
• A score of \>= 20 on the HAMD-17 at the time of enrollment and at baseline
• Episode duration will be greater than 4 weeks but not longer than 12 months.

You may not qualify if:

• Insufficiently responding to \>2 treatment strategies FDA/Health Canada-approved/guideline recommended for bipolar depression
• Acute manic or mixed episode
• An Axis I psychiatric disorder requiring primary clinical attention
• Clinically significant medical illness
• Treatment with minocycline or β-lactam antibiotics in the preceding 6 months
• Hypersensitivity to minocycline or any other tetracycline
• Physical injury requiring medical treatment or surgery in the last 6 months
• Pregnant or breast-feeding
• Inability to provide written informed consent.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (2)

• Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.

  PMID: 19895780 BACKGROUND

• Molina-Hernandez M, Tellez-Alcantara NP, Perez-Garcia J, Olivera-Lopez JI, Jaramillo-Jaimes MT. Antidepressant-like actions of minocycline combined with several glutamate antagonists. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Feb 15;32(2):380-6. doi: 10.1016/j.pnpbp.2007.09.004. Epub 2007 Sep 14.

  PMID: 17933448 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depression; Depressive Disorder, Major; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roger S McIntyre, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

CA (1)