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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT01809340
• Date of registration: 08/03/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression
• Scientific title: An Exploratory, Blinded, Randomized, Placebo-controlled Study in Subjects With Depressive Disorder to Investigate the Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced (Partial) Symptoms Response
• Date of first enrolment: June 2013
• Target sample size: 29
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01809340
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, France, Netherlands, Romania, Spain

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnostic criteria for moderate to severe major depressive disorder (MDD), without
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

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 more than 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, or immunologic diseases 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depressive Disorder

Intervention(s)

Drug: Minocycline

Drug: Ketamine

Drug: Placebo

Primary Outcome(s)

Proportion of patients (among responders) who survive relapse-free [Time Frame: Day 54]

Secondary Outcome(s)

Time to relapse (among responders) following completion of the IV ketamine infusion schedule and after first dose of minocycline/placebo [Time Frame: From Day 12 to Day 54]

Change in the MADRS total score from baseline during IV ketamine treatment phase [Time Frame: Days 1, 3, 5, 8, 10 and 12]

Change in MADRS total score among non-responders from pre-randomization to end-of-study [Time Frame: From Day 12 to Day 54]

Change in the MADRS total score from baseline after IV ketamine treatment phase [Time Frame: Days 1, 20, 27, 34, 41, 48, and 54]

Response (reduction = 50% in MADRS total score relative to baseline) rate during IV ketamine treatment phase [Time Frame: Days 1, 3, 5, 8, 10, and 12]

Change in C-SSRS from baseline to any time in the study [Time Frame: Days 1, 12, and 54]

Secondary ID(s)

CR100957

KETIVEDI2001

2012-002954-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors