Minocycline and Depression (MINDEP) study

Phase 1

• Conditions: Depression; MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-003413-26-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-03
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1.Be aged 25-60
2.Have a current DSM-IV diagnosis of nonpsychotic major depressive disorder, confirmed by the Mini International Neuropsychiatric Interview (MINI);
3.Be non-responders to the current antidepressant taken at therapeutic doses for at least 6 weeks, as indicated by a current score of at least 14 on the 17-item Hamilton Depression Rating Scale (HAMD);
4.Be tolerant to the current antidepressant, and accepting augmentation with minocycline;
5.Have CRP levels = 1 mg/L, indicative of mild-moderate inflammation;
6.Have the ability to understand and sign a written informed consent form prior to participation in any screening procedures and a willingness to comply with all trial requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.have active suicidal ideation of significant concern to require intensive monitoring by secondary psychiatry services;
2.have a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or substance/alcohol misuse disorder;
3.are taking warfarin;
4.have received tetracycline within the previous 2 months, or have a history of sensitivity or intolerance to this class of drugs;
5.have an acute infection; or have an autoimmune or inflammatory disorder, because of both the rare but described association between minocycline and systemic lupus erythematosus, and the potential confounder effects of these conditions on immune biomarkers.
6.have hepatic or renal failure
7.take any other psychotropic medications other than their current antidepressant that has not been approved by a study investigator prior to enrolment
8.Refuse that we contact their General Practitioner (GP) to inform them about their participation in the study.
9.(Females) Have a positive pregnancy test before starting the study/are unwilling to take a pregnancy test and are unwilling to agree to use an acceptable form of contraceptive throughout the study period (e.g. condoms, IUD/IUS, injection, patch, ring). Female participants who use combined oral contraceptives as their main form of birth control will need to use an additional barrier method for the duration of treatment and for 7 days following completion of treatment.
10.Breastfeeding (females)
11.Are currently participating in a clinical trial of an investigational medical product (CTIMP). For individuals who have been recently on CTIMP clinical trials, we will decide on case by case basis if they could be included in the trial according to the type of trial they have been involved in.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim is to investigate association between changes in inflammatory biomarkers and improvement in depressive symptoms following adjunctive treatment with minocycline in treatment resistant depressed patients selected for increased inflammation.;Secondary Objective: The secondary aim is to identify molecular inflammatory pathways involved in the response to anti-inflammatory treatment in the same patients.;Primary end point(s): Changes from baseline to Week 4 for Hamilton Depression Rating Scale total score, including the percentage of patients who show response, defined as 50% reduction in the baseline. ;Timepoint(s) of evaluation of this end point: Changes in depression scores will be evaluated at the end of the 4 weeks of treatment with either minocycline or placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical outcome: Changes from baseline to week 4 for Beck Depression Inventory, State and Trait Anxiety Inventory and Clinical Global Impression scale. <br><br>Biological outcome: Changes from baseline to Week 4 in cytokines and kynurenine pathway metabolites and transcriptomics.<br>;Timepoint(s) of evaluation of this end point: The changes in clinical symptoms and biological measurements will be evaluated at the end of the 4 weeks of treatment with either minocycline or placebo.