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Trial record 1 of 1 for:    NCT02263872
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Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02263872
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : September 5, 2016
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Pakistan Institute of Learning and Living

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. 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

Condition or disease Intervention/treatment Phase
Depressive Disorder Mood Disorders Depressive Disorder, Treatment Resistant Antidepressive Agents Drug: Minocycline Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial
Study Start Date : October 2014
Primary Completion Date : June 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Minocycline
Minocycline 200mg perday
Drug: Minocycline
Minocycline 200mg perday
Other Name: mesodrum
Placebo Comparator: comparison group with placebo
Placebo provide
Drug: Minocycline
Minocycline 200mg perday
Other Name: mesodrum



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

Secondary Outcome Measures :
  1. PHQ-9 [ Time Frame: Baseline, Week 2, week 4, week 8, week 12 ]
  2. GAD-7 [ Time Frame: Baseline, Week 2, week 4, week 8, week 12 ]
  3. CGI [ Time Frame: Baseline, Week 2, week 4, week 8, week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263872


Locations
Pakistan
Abasi Shaheed Hospital
Karachi, Sindh, Pakistan, 72000
Civil hospital Karachi
Karachi, Sindh, Pakistan, 72000
Karwan-e-Hayat
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Learning and Living
King's College London
Investigators
Principal Investigator: Dr. Muhammad Ishrat Institute of Psychiatry, Psychology and Neuroscience, Kings college London

Publications:
World Health Organization. The Global Burden of Disease. Geneva: WHO Press; 2012.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier: NCT02263872     History of Changes
Other Study ID Numbers: MINDEP001
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Mood Disorders
Depressive Disorder, Treatment-Resistant
Pathologic Processes
Mental Disorders
Behavioral Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents