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Trial registered on ANZCTR


Registration number
ACTRN12612000283875
Ethics application status
Approved
Date submitted
2/02/2012
Date registered
9/03/2012
Date last updated
22/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Minocycline as a new treatment for depression
Scientific title
The efficacy of minocycline as an adjunctive treatment in unipolar depression: A pilot study using change on MADRS as the primary outcome.
Secondary ID [1] 279843 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MINO-UD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unipolar depression 285727 0
Condition category
Condition code
Mental Health 285910 285910 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200 mg/day of oral (1 tablet bidaily) adjunctive minocycline will be trialled against placebo for 12 weeks to determine the efficacy of minocycline for the treatment of unipolar depression.
Intervention code [1] 284164 0
Treatment: Drugs
Comparator / control treatment
Placebo (inactive starch)
Control group
Placebo

Outcomes
Primary outcome [1] 286406 0
Change in depressive symptoms based on the Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 286406 0
Mixed model repeated measures analysis will be employed to investigate change over time between baseline and treatment endpoint (week 12). Time points to be included are; week 0 (baseline), week 2, week 4, week 6, week 8 and week 12.
Secondary outcome [1] 295789 0
Change in anxiety symptoms based on the Hamilton Anxeity Rating Scale (HAM-A)
Timepoint [1] 295789 0
Mixed model repeated measures analysis will be employed to investigate change over time between baseline and treatment endpoint (week 12). Time points to be included are; week 0 (baseline), week 2, week 4, week 6, week 8 and week 12.
Secondary outcome [2] 295795 0
Change in Clinical Global Impressions - Improvement Scale (CGI-I)
Timepoint [2] 295795 0
As there is no baseline for this scale, change is taken from week 2 to the end of the treatment phase (week 12).
Secondary outcome [3] 295796 0
Change in Clincial Global Impressions - Severity Scale (CGI-S)
Timepoint [3] 295796 0
Mixed model repeated measures analysis will be employed to investigate change over time between baseline and treatment endpoint (week 12). Time points to be included are; week 0 (baseline), week 2, week 4, week 6, week 8 and week 12.
Secondary outcome [4] 295797 0
Change in functioning based on the Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [4] 295797 0
Mixed model repeated measures analysis will be employed to investigate change over time between baseline and treatment endpoint (week 12). Time points to be included are; week 0 (baseline), week 2, week 4, week 6, week 8 and week 12.
Secondary outcome [5] 295798 0
Change in functioning based on the Range of Impaired Functioning Tool (LIFE/RIFT)
Timepoint [5] 295798 0
Mixed model repeated measures analysis will be employed to investigate change over time between baseline and treatment endpoint (week 12). Time points to be included are; week 0 (baseline), week 2, week 4, week 6, week 8 and week 12.
Secondary outcome [6] 295799 0
Change in quality of lifre based on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Timepoint [6] 295799 0
Mixed model repeated measures analysis will be employed to investigate change over time between baseline and treatment endpoint (week 12). Time points to be included are; week 0 (baseline), week 2, week 4, week 6, week 8 and week 12.
Secondary outcome [7] 295800 0
Analysis of inflammatory and oxidative biomarkers in peripheral blood samples (pending further funding)
Timepoint [7] 295800 0
Blood sampling will be conducted at baseline and the end of week 12 (end of treatment phase).
Secondary outcome [8] 295801 0
Changes in MADRS, CGI-I, CGI-S, HAM-A, SOFAS, LIFE/RIFT and Q-LES-Q following discontinuation of trial medication.
Timepoint [8] 295801 0
Analyses will be conducted between end of the treatment phase (week 12) and the post-discontinuation of treatment visit (week 16).
Secondary outcome [9] 295803 0
Investigation of safety and tolerability using adverse events (for example, changes in skin pigmentation)
Timepoint [9] 295803 0
Adverse events will be recorded at each visit (from week 2 to week 12) and comparisons will be made between minocycline and placebo to determine differences in the frequency of events.

Eligibility
Key inclusion criteria
-Aged 18 or over
-Capacity to consent to the study and to follow its instructions and procedures
-Fulfil the DSM-IV-TR diagnostic criteria for major depressive disorder, single episode or recurrent, as well as scoring 20 or over on the MADRS, at the baseline visit
-Participants on antidepressant therapy need to have been on the same treatment for at least two weeks prior to randomisation
-Utilising effective contraception (other than the contraceptive pill due to drug interactions) if female of child-bearing age and sexually active
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Concurrent diagnosis of bipolar disorder I, II or NOS -Three or more failed adequate trials of antidepressant therapy for the current major depressive episode or ECT for the current major depressive episode -Known or suspected clinically unstable systemic medical disorder (including a pre-existing infectious illness requiring tetracycline antibiotic treatment) -Pregnancy or breastfeeding -Contraindications to tetracyclines, including allergy or other intolerance; prior tetracycline use within 2 months of baseline visit -Current treatment with >5 mg beta caretone or >300 micrograms retinol equivalent. -Current treatment with anticoagulants; -Current treatment with methoxyflurane -Current treatment with penicillin -Females of childbearing age currently relying solely on the contraceptive pill as contraception.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be sequentially allocated to recieve a recruitment number. Recruitment numbers are listed on the medication bottles (which are identical in each arm) with both the clincian and participant being blind to treatment. The person responsible for the randomisation code is independent of the study interviews.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer permutated blocks are used to generate the randomisation sequence. Blocks include a 2X4 allocation of treatment arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6914 0
3220 - Geelong
Recruitment postcode(s) [2] 6915 0
3121 - Richmond
Recruitment outside Australia
Country [1] 6674 0
Thailand
State/province [1] 6674 0
Bangkok

Funding & Sponsors
Funding source category [1] 284614 0
Charities/Societies/Foundations
Name [1] 284614 0
Australasian Society for Bipolar and Depressive Disorders/Servier
Address [1] 284614 0
Level 8, Aikenhead Wing
27 Victoria Parade
Fitzroy VIC 3065 Australia
Country [1] 284614 0
Australia
Funding source category [2] 292750 0
Charities/Societies/Foundations
Name [2] 292750 0
Brain and Behavior Foundation
Address [2] 292750 0
Additional funding source was not original listed. Address:
Brain & Behavior Research Foundation
90 Park Avenue, 16th Floor
New York, NY 10016
Country [2] 292750 0
United States of America
Primary sponsor type
Other
Name
Mental Health Research Institute
Address
Kenneth Myer Building, The University of Melbourne,
Victoria, Autralia, 3000
Country
Australia
Secondary sponsor category [1] 283539 0
None
Name [1] 283539 0
Address [1] 283539 0
Country [1] 283539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286608 0
Barwon Health Research Ethics Committee
Ethics committee address [1] 286608 0
P.O. Box 281
Geelong, Victoria
3220
Ethics committee country [1] 286608 0
Australia
Date submitted for ethics approval [1] 286608 0
15/02/2012
Approval date [1] 286608 0
14/05/2012
Ethics approval number [1] 286608 0
11/146
Ethics committee name [2] 289324 0
The Melbourne Clinic HREC
Ethics committee address [2] 289324 0
130 Church St
Richmond Vic 3121
Australia
Ethics committee country [2] 289324 0
Australia
Date submitted for ethics approval [2] 289324 0
10/01/2013
Approval date [2] 289324 0
13/02/2013
Ethics approval number [2] 289324 0
#221

Summary
Brief summary
This study aims to investigate minocycline as an adjunctive treatment for unipolar depression. Participants will receive 200 mg/day of minocycline or placebo for 12 weeks with improvements on the MADRS being the primary outcome. Secondary outcomes include potential improvements in functioning, quality of life and clincial impressions. Based on previous studies, minocycline should be well-tolerated for the duration of the study, however safety monitoring will also be reported as a secondary outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33712 0
Dr Olivia Dean
Address 33712 0
Barwon Psychiatric Research Unit P.O. Box 281 Geelong, VIC 3220
Country 33712 0
Australia
Phone 33712 0
+613 4215 3300
Fax 33712 0
+61 3 4215 3491
Email 33712 0
oliviad@barwonhealth.org.au
Contact person for public queries
Name 16959 0
Dr Olivia Dean
Address 16959 0
Barwon Psychiatric Research Unit
P.O. Box 281
Geelong, VIC
3220
Country 16959 0
Australia
Phone 16959 0
+61 3 4215 3300
Fax 16959 0
+61 3 4215 3491
Email 16959 0
oliviad@barwonhealth.org.au
Contact person for scientific queries
Name 7887 0
Dr Olivia Dean
Address 7887 0
Barwon Psychiatric Research Unit
P.O. Box 281
Geelong, VIC
3220
Country 7887 0
Australia
Phone 7887 0
+61 3 4215 3300
Fax 7887 0
+61 3 4215 3491
Email 7887 0
oliviad@barwonhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary