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

Bipolar Disorder Clinical Trial

Official title:

Cognitive Deficits in Major Depressive Disorder and Bipolar Disorder Depressed Type: Prevalence and Symptoms With Treating of Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844974
• Other study ID #: 2007-p-001665
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: November 14, 2013
• Start date: December 2007
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognition Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Other:
• Prevalence
Mood and cognitive assessments

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the relationship between severity and type of depression with cognitive deficits		study duration	No