An Investigation of the Antidepressant Efficacy of the 5-HT2A Antagonist, M100907 in Combination With Escitalopram in Treatment Resistant Depression

Detailed Summary

This study will examine whether a highly specific and powerful 5-hydroxytryptamine 2A (5-HT2A) antagonist, M100907, combined with escitalopram, is responsible for an antidepressant effect. Major affective disorders are common and can be chronic and life threatening. Yet as many as 50 to 75 percent of patients get only a partial response to the use of antidepressants. Some do not respond to medications in the category of serotonin reuptake inhibitors (SSRIs)-or they experience side effects that sharply interfere with daily life. This study will determine the extent to which M100907 improves sleep and improves fatigue in people who are treated, and how it reduces cognitive impairment, that is, limitations to awareness, in the depressive syndrome. It will also look at allele frequencies as being covariates in the analysis and to collect data. Patients 18 to 65 years of age who meet the criteria for major depression, without psychotic features, may be eligible for this study. Women of childbearing potential must be using two medically accepted contraception methods and must agree to a (Beta)-HCG (human chorionic gonadotropin, a polypeptide hormone produced by the human placenta) test at the screening and at several intervals. In random groups, participants will receive treatment with escitalopram and either M100907 or a placebo. The timing of escitalopram can be adjusted to manage side effects. If already taking any other medications for psychiatric purposes, participants will be tapered from those medications and monitored. Participants will also undergo the following tests and procedures: * Test of vital signs, lying and standing * Physical exam * 12-lead electrocardiogram (SCG) * Psychiatric examination for screening * Thyroid screening * Collection of blood for chemistry and hematology * Hepatitis B and C/HIV screening * Beta-HCG pregnancy test, if applicable * Urine drug screening * Urinalysis * Tests using the Hamilton Depression Rating Scale and the Montgomery-Asburg Depression Rating Scale * Use of the Antidepressant Treatment History A sleep study will be conducted during the steady state period and again toward the end of the double blind treatment period. Each study will involve 2 consecutive nights of polysomnographic recording done by an EEG technologist experienced in using the technique.

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