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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: Completed Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00070694 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00070694 record still lists
NCT00070694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which MDL100.907 is the first listed.
NCT00070694 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00070694's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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