Wellbutrin XL Effects on SSRIs Induced Changes

Completed · Phase 4

Conditions studied: Depression, Side Effects, Sexual Dysfunction, Apathy

In brief

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.

Key facts

Study ID

NCT00456820

Run by

Indiana University

People needed

15

Starts

2004-07-01

Expected to finish

2007-11-01

Last updated by the study team

2007-10-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University Adult Psychiatry Clinic — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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