NCT04663321

Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)

A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the efficacy and safety of daily and intermittent dosing of MK-1942 compared to placebo among participants with Treatment-Resistant Depression (TRD) on a stable course of antidepressant therapy. The dual primary hypotheses of the study are that the daily MK-1942 treatment or intermittent MK-1942 treatment are superior to placebo in reducing Montgomery-Asberg Depression Rating Scale (MADRS) score.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	MK-1942	MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.
DRUG	Placebo	Dose matched placebo capsules BID orally over 4 weeks.

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2020-12-11
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

45 sites across 1 country: United States

Regulatory

• FDA-regulated drug study