Cognitive Deficits in Major Depressive Disorder and Bipolar Disorder, Depressed Type: Prevalence and Improvement With Treatment of Depressive Symptoms
1 other identifier
interventional
33
1 country
1
Brief Summary
The purpose of this research study is to learn more about cognitive deficits in people with certain mood disorders. The mood disorders are Major Depressive Disorder (MDD) and Bipolar disorder, depressed type. Cognitive deficits are problems with things like thinking and memory. People with cognitive deficits may have problems concentrating and paying attention. When talking, they may have trouble recalling a word they want to say. They may think slowly and have problems remembering things. These deficits can affect an individual's ability to work and function socially. Cognitive deficits that occur with depression may increase the risk of a relapse of major depressive disorder. We want to study the course of cognitive impairment in subjects as they are receiving treatment for their depression. We want to find out if their cognitive deficits get better, worse, or stay the same. We also want to learn more about a stress hormone called cortisol that is produced in the body. We want to study the relationship between cortisol and cognitive impairment. Recent research has shown that cognitive impairment may be more severe in people who have high levels of cortisol in their blood. We will also measure the levels of a protein in your blood called brain-derived neurotrophic factor (BDNF). BDNF helps the growth of new brain cells. It appears that the growth of new brain cells lessens when people are depressed. Treatment with antidepressant medications may cause BDNF levels to increase and return to normal. We are interested in studying the relationship between BDNF levels and cognitive impairment throughout treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 18, 2013
November 1, 2013
5 years
May 8, 2008
November 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To examine the relationship between severity and type of depression with cognitive deficits
study duration
Study Arms (1)
1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Eligible subjects will be inpatients admitted to the Massachusetts General Psychiatric inpatient service, Blake 11 with diagnoses of MDD with and without psychotic features and BPDD with and without psychotic features.
- Subjects will include men and women aged 18-85.
- Competent to give informed consent.
You may not qualify if:
- Patients with illnesses that impair cognitive functioning including: vascular dementia, and neurological illnesses including Parkinson's Disease, Huntington's Disease, multiple sclerosis, and Alzheimer's Disease.
- The following DSM-IV diagnoses: schizophrenia, schizoaffective disorder, delusional disorder, organic mental disorder, substance use disorders including alcohol, active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified.
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Matthews, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
May 8, 2008
First Posted
February 16, 2009
Study Start
December 1, 2007
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 18, 2013
Record last verified: 2013-11