The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Sy… (NCT01809340) | Clinical Trial Compass
TerminatedPhase 2
The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression
Stopped: study team decision because of IP supply issue and necessary amendment to protocol
Belgium, France29 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dru…
What they're measuring
1
Proportion of patients (among responders) who survive relapse-free