The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects with Depressio

Phase 1

• Conditions: Depressive Disorder; MedDRA version: 16.1Level: PTClassification code 10004940Term: Bipolar II disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 16.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-002954-21-BE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-21
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Diagnostic criteria for moderate to severe major depressive disorder (MDD), without mood incongruent psychotic features, or Bipolar Disorder Type II
- Patients should have an Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) total score = 34 at Screening and at Day 1 (predose)
- Patients with major depressive disorder should have failed at least two adequate treatment courses (dose and duration) with antidepressant therapy, one of which is in the current episode
- Patients should not have received electroconvulsive therapy (ECT) in the current episode but could be those for whom ECT is considered
- Patients with bipolar depression (BPD) Type II must have been taking a stable dose of a mood-stabilizing medication (e.g., lithium, valproate, carbamazepine, lamotrigine, antipsychotic agents) for at least 4 weeks, dosed clinically to target the therapeutic range
- Patients currently taking an antidepressant(s) must have received at least 2 weeks of stable antidepressant therapy at the time of Screening
- Doses of current antidepressant therapies should remain the same for the duration of the study
- Women must be postmenopausal, surgically sterile, or if heterosexually active, practicing a highly effective method of birth control
- Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

- Has a current DSM-IV axis I diagnosis other than MDD or BPD Type II at screening (except for co-morbid anxiety disorders)
- Has a diagnosis of substance abuse or dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
- Patient is currently taking > 4 psychotropic medications at Day 1 (predose)
- Has an autoimmune disorder such as Crohn’s disease, rheumatoid arthritis, psoriasis currently treated with/requiring treatment with immunomodulatory therapies
- Has any significant cardiovascular, respiratory, neurologic, renal, hepatic, endocrine, immunologic diseases, glaucoma, hypothyroidism or hyperthyroidism based on screening examination
- Has uncontrolled hypertension (diastolic blood pressure = 90 mmHg), despite diet, exercise or a stable dose of an allowed antihypertensive treatment, at Screening or Day 1 (predose)
- Has planned vaccination within 2 weeks prior to the first dose of study medication through 2 weeks after the last dose of study medication
- Has an active infectious disease/current infection
- Has known allergies, hypersensitivity, or intolerance to minocycline or ketamine or its excipients
- Has contraindications to the use of minocycline or ketamine per local prescribing information

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess whether the antidepressant response to IV ketamine can be maintained by minocycline compared to placebo.;Secondary Objective: To investigate the safety and tolerability of the administered study medications (i.e., ketamine and minocycline).<br><br>To investigate the effect of minocycline on symptoms of depression in ketamine non-responders.;Primary end point(s): The primary efficacy endpoint will be the proportion of subjects who survive relapse-free (among responders). ;Timepoint(s) of evaluation of this end point: Day 54 (Week 6) of the 6-week blinded treatment period.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. From Day 12 to Day 54. <br>2. Days 1, 3, 5, 8, 10, and 12. <br>3. Days 1, 20, 27, 34, 41, 48, and 54.<br>4. Days 1, 3, 5, 8, 10 and 12.<br>5. Day 12 to Day 54.<br>6. Day 1, 12 & 54. <br><br>;Secondary end point(s): 1. The change in MADRS total score among non-responders from pre-randomization to end-of-study. <br>2. Change in the MADRS total score from baseline during the IV ketamine treatment phase. <br>3. Change in the MADRS total score from baseline after IV ketamine treatment phase. <br>4. Response (reduction = 50% in MADRS total score relative to baseline) rate during the IV ketamine treatment phase. <br>5. Time to relapse (among responders) following completion of the IV ketamine infusion schedule.<br>6. Effect on Columbia Suicide Severity Rating Scale (C-SSRS).