Status:
COMPLETED
Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial
Lead Sponsor:
Pakistan Institute of Living and Learning
Collaborating Sponsors:
King's College London
Conditions:
Depressive Disorder
Mood Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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. Th...
Detailed Description
Major depressive disorder is associated with significant morbidity and mortality. According to the WHO, depression is the leading cause of disability worldwide in terms of years lost due to disability...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02263872
Start Date
October 1 2014
End Date
August 1 2016
Last Update
September 5 2016
Active Locations (3)
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1
Abasi Shaheed Hospital
Karachi, Sindh, Pakistan, 72000
2
Civil hospital Karachi
Karachi, Sindh, Pakistan, 72000
3
Karwan-e-Hayat
Karachi, Sindh, Pakistan