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

This study has been completed.
Sponsor:
Collaborator:
National Association for Research on Schizophrenia and Affective Disorders.
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00125957
First received: August 1, 2005
Last updated: April 20, 2012
Last verified: April 2012

August 1, 2005
April 20, 2012
August 2005
January 2010   (final data collection date for primary outcome measure)
  • Montgomery-Asberg Depression Rating Scale (MADRS) overall and question-specific scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • neuropsychiatric assessment changes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • MADRS overall and question-specific scores
  • neuropsychiatric assessment changes
  • hyperactivity measures
Complete list of historical versions of study NCT00125957 on ClinicalTrials.gov Archive Site
  • symptom self-report [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • hyperactivity measures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
self-report
Not Provided
Not Provided
 
The Effects of Bupropion on Residual and Cognitive Symptoms in SSRI-treated Depression
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Major Depressive Disorder
  • Unipolar Depression
Drug: bupropion
bupropion 150mg BID po
Placebo Comparator: 1
bupropion
Intervention: Drug: bupropion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125957
2005P-000502
No
Beth L. Murphy MD, PhD, Mclean Hospital
Mclean Hospital
National Association for Research on Schizophrenia and Affective Disorders.
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
Mclean Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP