Trial Outcomes & Findings for Antidepressant Effects of NR2B in Major Depression (NCT NCT00472576)

Results Overview

The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

Measured daily for 12 days, where the endpoint is the primary outcome

Results posted on

2012-08-03

Participant Flow

Patients were recruited to participate at the Clinical Center on the campus of the National Institutes of Health in Bethesda, Maryland.

24 patients were screened, 19 subjects were excluded as they did not meet criteria (total n=13) or refused to participate (n=6).

Participant milestones

Participant milestones
Measure	Placebo Then MK-0657 Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.	MK-0657 Then Placebo Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
First Intervention STARTED	2	3
First Intervention COMPLETED	2	3
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	2	3
Second Intervention COMPLETED	2	3
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antidepressant Effects of NR2B in Major Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then MK-0657 n=2 Participants Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.	MK-0657 Then Placebo n=3 Participants Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 0 • n=5 Participants	36 years STANDARD_DEVIATION 12 • n=7 Participants	43 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured daily for 12 days, where the endpoint is the primary outcome

Population: The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.

The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.	MK-0657 n=5 Participants Patients receive 4 to 8 mg of MK-0657 for 12 days.
Montgomery-Asberg Depression Rating Scale (MADRS)	22.519 Score on a scale Standard Error 2.091	23.633 Score on a scale Standard Error 2.091

SECONDARY outcome

Timeframe: Measured daily for 12 days, where the endpoint is primary

Population: The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.

The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.	MK-0657 n=5 Participants Patients receive 4 to 8 mg of MK-0657 for 12 days.
Hamilton Depression Rating Scale (HDRS)	15.671 Score on a scale Standard Error 1.319	13.380 Score on a scale Standard Error 1.319

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MK-0657

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=5 participants at risk Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.	MK-0657 n=5 participants at risk Patients receive 4 to 8 mg of MK-0657 for 12 days.
Reproductive system and breast disorders Decreased Libido	60.0% 3/5 • Number of events 3 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	60.0% 3/5 • Number of events 3 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Musculoskeletal and connective tissue disorders Muscle, bone, or joint pain	0.00% 0/5 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	20.0% 1/5 • Number of events 1 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Psychiatric disorders Tiredness/Fatigue	40.0% 2/5 • Number of events 2 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	20.0% 1/5 • Number of events 1 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Psychiatric disorders Difficulty falling asleep	40.0% 2/5 • Number of events 2 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	40.0% 2/5 • Number of events 2 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Psychiatric disorders Interrupted Sleep	60.0% 3/5 • Number of events 3 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	20.0% 1/5 • Number of events 1 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Psychiatric disorders Early morning awakening	0.00% 0/5 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	20.0% 1/5 • Number of events 1 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Psychiatric disorders Depression	20.0% 1/5 • Number of events 1 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.	40.0% 2/5 • Number of events 2 • Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.

Additional Information

Dr. Carlos Zarate

Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH

Phone: 301-451-0861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place