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Cognitive Deficits in Major Depressive Disorder and Bipolar Disorder, Depressed Type: Prevalence and Improvement With Treatment of Depressive Symptoms

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 16, 2009
Last Update Posted: November 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital

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.

Condition Intervention
Major Depression Bipolar Disorder Other: Prevalence

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Cognitive Deficits in Major Depressive Disorder and Bipolar Disorder Depressed Type: Prevalence and Symptoms With Treating of Depressive Symptoms

Resource links provided by NLM:

Further study details as provided by John D. Matthews, Massachusetts General Hospital:

Primary Outcome Measures:
  • To examine the relationship between severity and type of depression with cognitive deficits [ Time Frame: study duration ]

Enrollment: 33
Study Start Date: December 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Other: Prevalence
Mood and cognitive assessments


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Subjects will include men and women aged 18-85.
  3. Competent to give informed consent.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844974

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: John D Matthews, MD Massachusetts General Hospital
  More Information

Responsible Party: John D. Matthews, Assistant Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00844974     History of Changes
Other Study ID Numbers: 2007-p-001665
First Submitted: May 8, 2008
First Posted: February 16, 2009
Last Update Posted: November 18, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Cognition Disorders
Cognitive Dysfunction
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Neurocognitive Disorders