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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pakistan Institute of Learning and Living; Pakistan Institute of Living and Learning
• Collaborator: King's College London
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. patients aged 18-65 years

2. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of major depressive disorder

3. competent and willing to give informed consent

4. taking the current antidepressant medication for a minimum of 4 weeks prior to baseline

5. the current episode of depression has failed to remit with at least two courses of antidepressant treatment (one of which is the current course)

6. able to take oral medication

7. if female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.

Exclusion Criteria:

1. relevant medical illness (renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis)

2. prior history of intolerance to any of the tetracyclines

3. concomitant penicillin therapy

4. concomitant anticoagulant therapy

5. presence of a seizure disorder

6. currently taking valproic acid

7. any change of psychotropic medications within the previous 4 weeks

8. diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-IV criteria

9. pregnant or breast-feeding

10. presence of primary psychotic disorder.