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NCT00456820 · ClinicalTrials.gov registry record · Phase 4
Wellbutrin XL Effects on SSRIs Induced Changes
A Phase 4 study of Depression and Sexual Dysfunction, sponsored by Indiana University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00456820 is a Phase 4 study of Depression and Sexual Dysfunction that has completed, run by Indiana University School of Medicine. The registered enrollment target is 15 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00456820, a Phase 4 study of Depression and Sexual Dysfunction, has completed, sponsored by Indiana University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to find out differences in activation of mood regulating areas of the brain in response to negative and positive pictures, before and after 6 weeks of additional Wellbutrin XL treatment. Participants should have been treated for depression with an SSRI medication (e.g., Prozac, Zoloft, Paxil, Celexa or Lexapro) and have decreased depression symptoms but also be experiencing side effects of medications such as sexual side effects and feelings of apathy (indifference, lack of interest) and lack of full emotional response. We will first take a brain scan to measure activity in different parts of the brain, while subjects are seeing pictures, using Magnetic Resonance Imaging (MRI) scan. Then we will add Wellbutrin XL - another well-known antidepressant that acts by increasing the chemical dopamine in the brain, to subjects' treatment. Wellbutrin addition is useful in decreasing the sexual side effects of SSRIs. After treatment with Wellbutrin XL for 6 weeks subjects will have a second MRI scan with picture rating.
Conditions Studied
Interventions
- DRUG Wellbutrin XL
Study Locations (1)
Indiana
- Indiana University Adult Psychiatry Clinic - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00456820
The ClinicalTrials.gov registry entry for NCT00456820 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The listed sponsor is Indiana University School of Medicine, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Wellbutrin XL is the first listed.
NCT00456820 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT00456820 about?
NCT00456820 is a clinical study titled "Wellbutrin XL Effects on SSRIs Induced Changes". The purpose of this study is to find out differences in activation of mood regulating areas of the brain in response to negative and positive pictures, before and after 6 weeks of additional Wellbutrin XL treatment. Participants should have been treated for depression with an SSRI medication (e.g., ...
What is the current status of trial NCT00456820?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2004-07. Estimated completion is 2007-11.
What conditions does trial NCT00456820 study?
This clinical trial studies the following conditions: Depression, Sexual Dysfunction, Apathy, Side Effects.
What interventions are being tested in trial NCT00456820?
The interventions under investigation include: Wellbutrin XL (DRUG).
Who is sponsoring clinical trial NCT00456820?
This trial is sponsored by Indiana University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00456820 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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