The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects with Depressio
- Conditions
- Depressive DisorderMedDRA version: 16.1Level: PTClassification code 10004940Term: Bipolar II disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 16.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-002954-21-ES
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- 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
- 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 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. Change in Columbia Suicide Severity Rating Scale (C-SSRS). ;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>3. Days 1, 3, 5, 8, 10 and 12.<br>4. Day 12 to Day 54.<br>5. Day 1, 12 & 54.