Conditions: Depression
Keywords: randomized placebo controlled maximum tolerated dose
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: no

Brief summary:
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.

Detailed description:
This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg twice a day \[BID\] to 300 mg BID) or placebo for up to 16 days. In Part 2, a new cohort of participants will be randomly assigned to receive 100 mg BID of MK-8777, 400 mg BID of MK-8777, or placebo. Following titration (3 days per step), participants will be maintained on the assigned BID dose until Day 27, followed by one day of once a day (QD) dosing, for a total of 28 days. There were 11 treatment arms in total for Part 1 and Part 2 (see Interventions).

Arms:
arm 1: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. arm 2: Participants receive placebo BID for a total of 16 days. arm 3: Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. arm 4: Participants receive placebo BID for a total of 13 days. arm 5: Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. arm 6: Participants receive placebo BID for a total of 10 days. arm 7: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. arm 8: Participants receive placebo BID for a total of 13 days. arm 9: Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. arm 10: Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. arm 11: Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.

Interventions: intervention 1: MK-8777 intervention 2: Placebo
Intervention descriptions: intervention 1: Orally administered capsules containing either 50 mg or 100 mg MK-8777. intervention 2: Orally administered matching placebo capsules.

Protocol document: