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

Sponsor:	Mclean Hospital
Collaborator:	National Association for Research on Schizophrenia and Affective Disorders.
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00125957

Purpose

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effects of Bupropion on Residual and Cognitive Symptoms in SSRI-treated Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

symptom self-report [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
hyperactivity measures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2011
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 bupropion	Drug: bupropion bupropion 150mg BID po

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125957

Locations

United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Mclean Hospital

National Association for Research on Schizophrenia and Affective Disorders.

Investigators

Principal Investigator:

Beth L Murphy, MD, PhD

Mclean Hospital

More Information

Additional Information:

Web site for McLean hospital with links to research. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Beth Murphy MD, PhD, McLean Hospital
ClinicalTrials.gov Identifier:	NCT00125957 History of Changes
Other Study ID Numbers:	2005P-000502
Study First Received:	August 1, 2005
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mclean Hospital:

depression
serotonin
norepinephrine
SSRI

bupropion
executive function
residual symptoms

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Neurobehavioral Manifestations
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupropion
Antidepressive Agents, Second-Generation

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012