The Effects of Bupropion on Residual and Cognitive Symptoms in SSRI-Treated Depression

Condition(s) targeted: Depression; Major Depressive Disorder; Unipolar Depression

Intervention: bupropion (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mclean Hospital

Official(s) and/or principal investigator(s):
Beth L Murphy, MD, PhD, Principal Investigator, Affiliation: Mclean Hospital

Overall contact:
Sue B, Phone: 617-855-3184

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.

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

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

Primary outcome:

Montgomery-Asberg Depression Rating Scale (MADRS) overall and question-specific scores

neuropsychiatric assessment changes

Secondary outcome:

symptom self-report

hyperactivity measures

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Sue B, Phone: 617-855-3184

McLean Hospital, Belmont, Massachusetts 02478, United States; Recruiting
Jen O, Phone: 617-855-2915
Jin K, Phone: 617-855-2540
Beth L Murphy, MD, PhD, Principal Investigator
J. Alexander Bodkin, MD, Sub-Investigator

Web site for McLean hospital with links to research.

Starting date: August 2005
Ending date: December 2008
Last updated: January 17, 2008