Status:
COMPLETED
Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression
Lead Sponsor:
University Health Network, Toronto
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 th...
Detailed Description
Bipolar disorder (BD) is associated with a high-rate of non-recovery, recurrence, and inter-episodic dysfunction. Depressive symptoms and episodes dominate the longitudinal course of BD and differenti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01403662
Start Date
July 1 2011
End Date
December 1 2014
Last Update
December 19 2016
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5T 2S8