Antidepressant Effects of NR2B in Major Depression

This study has been completed.

Study NCT00472576 Information provided by National Institutes of Health Clinical Center (CC)

First Received on May 10, 2007. Last Updated on May 23, 2011 History of Changes

Results First Received: March 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Major Depression
Interventions:	Drug: MK-0657 Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited to participate at the Clinical Center on the campus of the National Institutes of Health in Bethesda, Maryland.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 patients were screened, 19 subjects were excluded as they did not meet criteria (total n=13) or refused to participate (n=6).

Reporting Groups

	Description
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.

Participant Flow for 2 periods

Period 1: First Intervention

	Placebo Then MK-0657	MK-0657 Then Placebo
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Period 2: Second Intervention

	Placebo Then MK-0657	MK-0657 Then Placebo
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.

Baseline Measures

	Placebo Then MK-0657	MK-0657 Then Placebo	Total
Number of Participants [units: participants]	2	3	5
Age [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	2	3	5
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	55 ± 0	36 ± 12	43 ± 13
Gender [units: participants]
Female	1	1	2
Male	1	2	3
Region of Enrollment [units: participants]
United States	2	3	5

Outcome Measures

Show All Outcome Measures

1. Primary:

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Measured daily for 12 days ]

Show Outcome Measure 1

2. Secondary:

Hamilton Depression Rating Scale (HDRS) [ Time Frame: Measured daily for 12 days ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was ended early due to recruitment problems.

Results Point of Contact:

Name/Title: Dr. Carlos Zarate
Organization: Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
phone: 301-451-0861
e-mail: zaratec@mail.nih.gov

Publications:

Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. Review. No abstract available.

Adamec RE, Burton P, Shallow T, Budgell J. Unilateral block of NMDA receptors in the amygdala prevents predator stress-induced lasting increases in anxiety-like behavior and unconditioned startle--effective hemisphere depends on the behavior. Physiol Behav. 1999 Jan 1-15;65(4-5):739-51.

Aguado L, San Antonio A, Perez L, del Valle R, Gomez J. Effects of the NMDA receptor antagonist ketamine on flavor memory: conditioned aversion, latent inhibition, and habituation of neophobia. Behav Neural Biol. 1994 May;61(3):271-81.

Responsible Party:	Dr. Carlos A. Zarate, Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
ClinicalTrials.gov Identifier:	NCT00472576 History of Changes
Other Study ID Numbers:	070152, 07-M-0152
Study First Received:	May 10, 2007
Results First Received:	March 14, 2011
Last Updated:	May 23, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration