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DepressionPhase 4NCT00456820

Wellbutrin XL Effects on SSRIs Induced Changes

A Phase 4 study testing Wellbutrin XL in people with Depression and Side Effects, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Depression, Side Effects, Sexual Dysfunction
What is being tested?
Wellbutrin XL
How many people
15 participants
Where
1 siteUnited States
Study dates
Jul 2004to Nov 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Adult Psychiatry Clinic

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Wellbutrin XL
Keywords
Mood Regulating Circuit, SSRI, fMRI
Medical subject headings
Depression, Sexual Dysfunction, Physiological, Lethargy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wellbutrin XLDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (3)

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2007 (estimated)
  2. Study startJul 2004
  3. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00456820
Sponsor's protocol ID
0406-27
Other IDs
45-870-26
Status last verified
Apr 2007
First submitted
14 Sep 2005
Last updated
16 Oct 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Wellbutrin XL in people with Depression and Side Effects, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activation and connectivity of frontal cortex and limbic region as measured by MRI scan at baseline and six weeks from baseline. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00456820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2007.

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Wellbutrin XL Effects on SSRIs Induced Changes | AzTrials