Depressive Disorder, Treatment-Resistant Clinical Trial
Official title:
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.
This is a randomized, double-blind (neither the researchers nor the participants know what treatment the participant is receiving), active-controlled, multicenter study (more than 1 study site) in elderly participants with TRD to assess the efficacy, safety, and tolerability of flexible doses of intranasal esketamine plus a newly initiated oral antidepressant compared with a newly initiated oral antidepressant (active comparator) plus intranasal placebo. The study will consist of 3 phases: Screening/Prospective Observational Phase (4 to 7 weeks), Double-blind induction Phase (4 weeks), Follow up Phase (2 weeks). Participants who rollover into a long-term open-label safety study will not participate in the Follow-up Phase. At the start of the Screening/Prospective observational Phase, participant must have had documented nonresponse to at least one antidepressant treatment (based on Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [MGH-ATRQ] criteria) in the current episode of depression, and the participant is taking a different oral antidepressant treatment on the MGH-ATRQ for at least the previous 2 weeks at or above the minimum therapeutic dose. This antidepressant treatment will be discontinued prior to the double-blind induction Phase. Participants taking benzodiazepines (at dosages equal to or less than the equivalent of 6 mg/day of lorazepam) and/or permitted non-benzodiazepine sleep medications (example, zolpidem, zaleplon) during the screening/prospective observational phase can continue these medications. All participants will start with first dose (Day 1 as 28 milligram [mg]); second dose (Day 4) is either 28 or 56 mg. All subsequent doses may be 28, 56 or 84 mg. After the first dose, all dosing decisions are determined by the investigator based on efficacy and tolerability. In addition, each participant will be assigned to receive 1 of 4 oral antidepressant medications from 2 different classes of antidepressant treatments, a Selective Serotonin Reuptake Inhibitor (SSRI) (escitalopram or sertraline) or a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) [duloxetine or venlafaxine extended release (XR)], initiated on Day 1 and continued through the double-blind induction Phase. Participants will be primarily evaluated for improvement in depressive symptoms as assessed by change in Montgomery Asberg Depression Rating Scale (MADRS) total score at Week 4. Participants' safety will be monitored throughout the study. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03851380 -
Improving Brain Stimulation Through Imaging
|
||
Completed |
NCT04977674 -
Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine
|
Early Phase 1 | |
Completed |
NCT03207282 -
Treatment Resistant Depression in America Latina
|
||
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Completed |
NCT02691520 -
Epidemiology of Treatment Resistant Depression in Taiwan
|
Phase 4 | |
Active, not recruiting |
NCT04159012 -
NESBID: Neuro-Stimulation of the Brain in Depression
|
N/A | |
Recruiting |
NCT05870501 -
Synaptic Imaging and Network Activity in Treatment Resistant Depression
|
N/A | |
Completed |
NCT04239651 -
rTMS With and Without iCBT For the Treatment of Resistant Depression (TRD)
|
N/A | |
Completed |
NCT02493868 -
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
|
Phase 3 | |
Completed |
NCT04599855 -
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
|
Phase 4 | |
Completed |
NCT03283670 -
Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
|
Phase 2 | |
Recruiting |
NCT03004521 -
Lithium Versus Quetiapine in Treatment Resistant Depression
|
Phase 4 | |
Recruiting |
NCT04783103 -
Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
|
N/A | |
Completed |
NCT03434041 -
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
|
Phase 3 | |
Terminated |
NCT03887624 -
Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression.
|
Early Phase 1 | |
Completed |
NCT02577250 -
Ketamine Infusions for PTSD and Treatment-Resistant Depression
|
Phase 1 | |
Recruiting |
NCT02610712 -
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
|
Phase 4 | |
Completed |
NCT03051256 -
Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
|
Phase 2 | |
Enrolling by invitation |
NCT05581797 -
Psilocybin-assisted Interpersonal Therapy for Depression
|
N/A | |
Completed |
NCT02782104 -
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
|
Phase 3 |