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NCT00070694 · ClinicalTrials.gov registry record · Phase 2
An Investigation of the Antidepressant Efficacy of the 5-HT2A Antagonist, M100907, in Combination With Citalopram in Treatment Resistant Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT00070694 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 96 participants.
The verdict
NCT00070694, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study 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 Montgomer
Interventions
- DRUG MDL100.907
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2003-09 |
| Est. Completion | 2004-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00070694
The ClinicalTrials.gov registry entry for NCT00070694 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MDL100.907 is the first listed.
NCT00070694 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00070694 about?
NCT00070694 is a clinical study titled "An Investigation of the Antidepressant Efficacy of the 5-HT2A Antagonist, M100907, in Combination With Citalopram in Treatment Resistant Depression". 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 o...
What is the current status of trial NCT00070694?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2003-09. Estimated completion is 2004-10.
What interventions are being tested in trial NCT00070694?
The interventions under investigation include: MDL100.907 (DRUG).
Who is sponsoring clinical trial NCT00070694?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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