Official Title: “The Effects of Bupropion on Residual and Cognitive Symptoms in SSRI-Treated Depression”

Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of bupropion.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: August 2008

As many as 65-75% of treated patients continue to experience residual symptoms of depression.

Cognitive impairments feature frontal cognitive dysfunction. Many experts believe that executive functions are better predictors of functional level than psychiatric diagnoses.

Frontal cognitive impairment and changes in neuroimaging are seen in individuals depleted of tryptophan, a serotonin precursor. These cognitive changes do not improve following serotonin-specific reuptake inhibitor treatment and at least one study has found that executive dysfunction predicts non-response to fluoxetine. In many patients, remission of mood symptoms in depression requires medications to target non-serotonergic neurotransmitter systems. Brain areas mediating executive functions receive rich noradrenergic inputs, and norepinephrine is known to be intimately involved in many of the executive functions.

A better understanding of serotonergic and catecholaminergic interactions would enable evidence-based treatment of depression which maximizes executive cognitive functions. This study examines the hypothesis that individuals treated with bupropion will have higher scores on tests of executive functions and lower scores on depression indices.

Intervention(s) in this Clinical Trial

• Drug: bupropion
  • bupropion 150mg BID po

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • bupropion

Primary Measures

• Montgomery-Asberg Depression Rating Scale (MADRS) overall and question-specific scores
  • Time Frame: 8 weeks
    Safety Issue?: No
• neuropsychiatric assessment changes
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• symptom self-report
  • Time Frame: 8 weeks
    Safety Issue?: No
• hyperactivity measures
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Depression
• SSRI-treated

Exclusion Criteria:

• Bipolar disorder
• Serotonin-norepinephrine reuptake inhibitor (SNRI) or bupropion treatment
• Treatment-resistant depression
• Seizure disorder
• Bulimia or anorexia nervosa
• Pregnancy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mclean Hospital

Overall Clinical Trial Officials and Contacts

Beth L Murphy, MD, PhD Principal Investigator Mclean Hospital  

Overall Contact: Sue B 617-855-3184 

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00125957

Study ID Number: 2005P-000502

ClinicalTrials.gov Identifier: NCT00125957

Health Authority: United States: Institutional Review Board

Web site for McLean hospital with links to research.