- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456820
Wellbutrin XL Effects on SSRIs Induced Changes
Wellbutrin XL Effects on SSRIs Induced Changes in the Reactivity of the Frontal Cortex and Limbic System to Emotional Stimuli: An fMRI Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Adult Psychiatry Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 18 - 60 years and able to give voluntary informed consent.
- Satisfy criteria for recent treatment with for Major Depressive Episode using DSM-IV episode recently treated with an adequate dose of an SSRI (sertraline, paroxetine, fluoxetine, citalopram, escitalopram) with 17-item Hamilton Depression Rating Scale (HDRS) score < 18.
- Complaining of symptoms of apathy, lack of feeling or sexual dysfunction with AES score < 10 and/or MADRAS item 8 (inability to feel > 1) and/or CSFQ score > 10
- Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire. 5) Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following - Symptoms not worsening by more than 10 points on the HDRS during the course of the study and not representing danger to self or others.
Exclusion Criteria:
- Meeting DSM-IV criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, primary anxiety disorder, mental retardation, or organic mental (including organic mood) disorder.
- Use of neuroleptic in the past 1 year.
- History of seizure disorder
- History of eating disorders such as bulimia or anorexia nervosa
- History of lack of response or intolerance to bupropion.
- Use of mood stabilizers in the past 2 weeks.
- Use of benzodiazepines in the past 2 weeks.
- Acutely suicidal or homicidal or requiring inpatient treatment.
- Meeting DSM-IV criteria for other substance dependence, including alcohol within the 6 months, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
- Use of alcohol in the past 1 week.
- No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
- Abnormal TSH values. If on synthroid should be on a stable dose for 3 months prior to the study with no changes during the study.
- Current pregnancy or breast-feeding.
- Metallic implants.
- Previously known positive HIV blood test (as latent central dysfunction may be present) as reported by the subject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Activation and connectivity of frontal cortex and limbic region as measured by MRI scan at baseline and six weeks from baseline
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Improvement of scores on Apathy Evaluation Scale and Changes in Sexual Functioning Questionnaire given weekly for six weeks
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Secondary Outcome Measures
Outcome Measure |
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Improvement of scores on Hamilton Depression Rating Scale given weekly for six weeks
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Improvement on Clinical Global Impression Severity and Improvement Scales given weekly for six weeks
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Improvement of scores on MADRS (specifically item #8) given weekly for six weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Depression
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
Other Study ID Numbers
- 0406-27
- 45-870-26
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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