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NCT00174876 · ClinicalTrials.gov registry record · Phase 2
Aripiprazole as Augmentation for TRD
A Phase 2 study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00174876 is a Phase 2 study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 20 participants.
The verdict
NCT00174876, a Phase 2 study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
A sizeable minority of patients suffering from major depression do not have their full set of depressive symptoms relieved by a single medication. Often times, a second medication is added to a patient's first antidepressant to obtain a better response in hopes of getting the depressed patient into full remission from symptoms. A typical psychiatric approach of recent has been to add one of the newer anti-schizophrenia medications to an existing FDA approved antidepressant in order to achieve better serotonin levels in the depressed patient's brain. This optimization of brain serotonin helps to alleviate more depressive symptoms. The newest antipsychotic medication to be FDA approved is Aripiprazole (Abilify). It may be particularly effective as it may safely elevate sertotonin through receptor 1a stimulation, receptor 2a blockade. It may also facilitate low levels of dopamine transmission which is truly novel for this agent when compared to other schizophrenia drugs. Depressed patients also tend to lack dopamine in their brains. This makes Aripiprazole and ideal agent to boost both serotonin and dopamine simultaneously. In theory, this may be an effective way to alleviate more depressive symptoms. The author suggests to enroll 10 subjects initially in open label fashion to take Aripiprazole plus their current FDA approved antidepressant to see if further elimination of depressive symptoms occurs and to show this pharmacological approach as a tolerable combination of medications. If there are no major safety issues, an amendment to allow 10 additional subjects will be forwarded to provide a better tolerability sample size.
Interventions
- DRUG Drug Abilify
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00174876
The ClinicalTrials.gov registry entry for NCT00174876 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Drug Abilify is the first listed.
NCT00174876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00174876 about?
NCT00174876 is a clinical study titled "Aripiprazole as Augmentation for TRD". A sizeable minority of patients suffering from major depression do not have their full set of depressive symptoms relieved by a single medication. Often times, a second medication is added to a patient's first antidepressant to obtain a better response in hopes of getting the depressed patient into ...
What is the current status of trial NCT00174876?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2004-07. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00174876?
The interventions under investigation include: Drug Abilify (DRUG).
Who is sponsoring clinical trial NCT00174876?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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