Protocol Number: 07-M-0152

Title:

An Investigation of the Antidepressant Effects of the Selective NR2B Antagonist MK-0657 in Major Depression

Number:

07-M-0152

Summary:

Purpose : This study will determine whether MK-0657, a Selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression.

MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response.People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded.Participants are admitted to the NIH Clinical Center for two study phases, as follows:Phase I (1 to 2 weeks): Patients are tapered off their current medications.Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657.Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day.

Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

NMDA Receptor

Depression Treatment

Unipolar Depression

Treatment Resistant

Glutamatergic

Recruitment Keyword(s):

Depression

Major Depression

Condition(s):

Major Depression

Investigational Drug(s):

MK-0657

Investigational Device(s):

None

Interventions:

Drug: MK-0657

Supporting Site:

National Institute of Mental Health

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93.

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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