Antidepressant Effects of NR2B in Major Depression

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00472576

First received: May 10, 2007

Last updated: July 19, 2012

Last verified: July 2012

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

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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

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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.
Total	Total of all reporting groups

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

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1. Primary:

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Measured daily for 12 days, where the endpoint is the primary outcome ]

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2. Secondary:

Hamilton Depression Rating Scale (HDRS) [ Time Frame: Measured daily for 12 days, where the endpoint is primary ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Publications automatically indexed to this study:

Ibrahim L, Diaz Granados N, Jolkovsky L, Brutsche N, Luckenbaugh DA, Herring WJ, Potter WZ, Zarate CA Jr. A Randomized, placebo-controlled, crossover pilot trial of the oral selective NR2B antagonist MK-0657 in patients with treatment-resistant major depressive disorder. J Clin Psychopharmacol. 2012 Aug;32(4):551-7.

Responsible Party:	Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
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:	July 19, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

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