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TerminatedPhase 2

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

NCT01809340 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 2
Phase
29
Target enrolment
12
Study sites
Outside the US

What it is testing

Summary

The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Proportion of patients (among responders) who survive relapse-free

    Measured over Day 54

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 80 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

12 study sites

FacilityCityRegionCountry
DuffelBelgium
LedeBelgium
LeuvenBelgium
BesançonFrance
Clermont-FerrandFrance
NîmesFrance
LeidenNetherlands
AlicanteSpain
BarcelonaSpain
CosladaSpain
MadridSpain
ZamoraSpain

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01809340 on ClinicalTrials.gov →

Last updated in the registry 2015-06-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits