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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2016
• Main ID: NCT02263872
• Date of registration: 08/10/2014
• Prospective Registration: No
• Primary sponsor: Pakistan Institute of Learning and Living
• Public title: Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial
• Scientific title: Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial
• Date of first enrolment: October 2014
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02263872
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Pakistan

Contacts

• Name: Dr. Muhammad Ishrat
• Affiliation: Institute of Psychiatry, Psychology and Neuroscience, Kings college London

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Antidepressive Agents

Depressive Disorder, Treatment Resistant

Mood Disorders

Depressive Disorder

Intervention(s)

Drug: Minocycline

Primary Outcome(s)

The primary clinical outcome measures will be mean change from baseline on the Hamilton Depression Scale scores [Time Frame: 12 weeks]

Secondary Outcome(s)

CGI [Time Frame: Baseline, Week 2, week 4, week 8, week 12]

GAD-7 [Time Frame: Baseline, Week 2, week 4, week 8, week 12]

PHQ-9 [Time Frame: Baseline, Week 2, week 4, week 8, week 12]

Secondary ID(s)

MINDEP001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

King's College London