Wellbutrin XL Effects on SSRIs Induced Changes

NCT00456820 | Completed Phase 4

• 2 other identifiers: 0406-2745-870-26
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Side Effects; Sexual Dysfunction; Apathy

Keywords

Mood Regulating Circuit; SSRI; fMRI

Outcome Measures

Primary Outcomes (2)

• Activation and connectivity of frontal cortex and limbic region as measured by MRI scan at baseline and six weeks from baseline

• Improvement of scores on Apathy Evaluation Scale and Changes in Sexual Functioning Questionnaire given weekly for six weeks

Secondary Outcomes (3)

• Improvement of scores on Hamilton Depression Rating Scale given weekly for six weeks

• Improvement on Clinical Global Impression Severity and Improvement Scales given weekly for six weeks

• Improvement of scores on MADRS (specifically item #8) given weekly for six weeks

Interventions

Wellbutrin XL DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Adult Psychiatry Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depression; Sexual Dysfunction, Physiological; Lethargy

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Genital Diseases; Urogenital Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Amit Anand, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: April 5, 2007
• Study Start: July 1, 2004
• Study Completion: November 1, 2007
• Last Updated: October 16, 2007

Record last verified: 2007-04

Locations

US (1)