Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00456820
Status:
COMPLETED
Last Update Posted:
2007-10-16
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wellbutrin XL Effects on SSRIs Induced Changes
Sponsor:
Indiana University School of Medicine
Organization:
Study Overview
Official Title:
Wellbutrin XL Effects on SSRIs Induced Changes in the Reactivity of the Frontal Cortex and Limbic System to Emotional Stimuli: An fMRI Study
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Hypotheses:
Hypothesis 1.After wellbutrin XL addition for 6 weeks, SSRI treated subjects will show increased activation and connectivity of prefrontal cortex and limbic regions such as the amygdala on exposure to negative and positive pictures
Hypothesis 2.Increase in activation of the MRC (Mood Regulating Circuit) will correlate with decrease in Apathy Evaluation Scale (AES) score and Sexual Dysfunction Score.
We plan to study a maximum of 15 subjects in this study. SSRI treated depressed patients who after treatment of depression continue to suffer from sexual dysfunction and apathy will be included in the study. fMRI will be conducted at baseline and after addition of Wellbutrin XL treatment 300 mg po qd and then used at a dose of 300 mg - 450 mg from week 3 - 6 depending on response and tolerance. Patients will also be rated weekly on 17-item Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale (MADRAS) (Montgomery and Asberg 1979), AES (Marin et al 1991), Changes in Sexual Functioning Questionnaire (CSFQ) and Clinical Global Impression (Improvement) weekly for 6 weeks. Depressed patients will also be rated on the scan days on cognitive measures such as verbal memory and working memory.
Hypothesis 1.After wellbutrin XL addition for 6 weeks, SSRI treated subjects will show increased activation and connectivity of prefrontal cortex and limbic regions such as the amygdala on exposure to negative and positive pictures
Hypothesis 2.Increase in activation of the MRC (Mood Regulating Circuit) will correlate with decrease in Apathy Evaluation Scale (AES) score and Sexual Dysfunction Score.
We plan to study a maximum of 15 subjects in this study. SSRI treated depressed patients who after treatment of depression continue to suffer from sexual dysfunction and apathy will be included in the study. fMRI will be conducted at baseline and after addition of Wellbutrin XL treatment 300 mg po qd and then used at a dose of 300 mg - 450 mg from week 3 - 6 depending on response and tolerance. Patients will also be rated weekly on 17-item Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale (MADRAS) (Montgomery and Asberg 1979), AES (Marin et al 1991), Changes in Sexual Functioning Questionnaire (CSFQ) and Clinical Global Impression (Improvement) weekly for 6 weeks. Depressed patients will also be rated on the scan days on cognitive measures such as verbal memory and working memory.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 45-870-26 | None | None | View |