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Sponsors and Collaborators: |
Mclean Hospital National Association for Research on Schizophrenia and Affective Disorders. |
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Information provided by: | Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT00125957 |
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.
Condition | Intervention | Phase |
---|---|---|
Depression Major Depressive Disorder Unipolar Depression |
Drug: bupropion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effects of Bupropion on Residual and Cognitive Symptoms in SSRI-Treated Depression |
Estimated Enrollment: | 30 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
bupropion
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Drug: bupropion
bupropion 150mg BID po
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sue B | 617-855-3184 |
United States, Massachusetts | |
McLean Hospital | Recruiting |
Belmont, Massachusetts, United States, 02478 | |
Contact: Jeanne L 617-855-2915 | |
Contact: Jin K 617-855-2540 | |
Principal Investigator: Beth L Murphy, MD, PhD | |
Sub-Investigator: J. Alexander Bodkin, MD |
Principal Investigator: | Beth L Murphy, MD, PhD | Mclean Hospital |
Responsible Party: | McLean Hospital ( Beth Murphy MD, PhD ) |
Study ID Numbers: | 2005P-000502 |
Study First Received: | August 1, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00125957 |
Health Authority: | United States: Institutional Review Board |
depression serotonin norepinephrine SSRI |
bupropion executive function residual symptoms |
Depression Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms Signs and Symptoms Dopamine |
Mental Disorders Bupropion Norepinephrine Mood Disorders Neurologic Manifestations Neurobehavioral Manifestations |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs |
Pharmacologic Actions Therapeutic Uses Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |