Status:
COMPLETED
Cognitive Training for Mood and Anxiety Disorders
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Major Depressive Disorder
Depression
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of a computerized cognitive training program (an attention and memory exercise performed on a computer) on thinking and memory in individuals wi...
Detailed Description
The objective of this research protocol is to collect feasibility and pilot data investigating the efficacy of a computerized cognitive training paradigm. The training paradigm aims to enhance cogniti...
Eligibility Criteria
Inclusion
- Primary, current Axis I diagnosis of a mood disorder (e.g., major depressive disorder (MDD); bipolar disorder, currently depressed) or anxiety disorder (PTSD; Generalized Anxiety Disorder (GAD); Social Phobia) according to DSM-IV criteria and SCID-IV diagnosis OR must be free of any psychiatric condition (for the healthy volunteer group)
- Age 18-80
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
Exclusion
- A history of drug or alcohol abuse or dependence (DSM-IV criteria) within the previous 6 months
- Visual impairment that would affect the ability to observe the computerized exercises
- Motor impairment that would affect the ability to provide a response by quickly pressing a button
- Patients with mood congruent or mood incongruent psychotic features
- Primary, current Axis I diagnosis other than MDD, Bipolar Disorder (currently depressed), PTSD, GAD or Social Phobia
- The presence of axis II personality disorder psychopathology that, in the opinion of the investigator, will interfere with study participation
- Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
- Pregnancy in women. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason. A urine pregnancy test will be administered at screening
- Enrolled participants can be currently taking standard antidepressant or mood stabilizer medication regimens, or benzodiazepine treatment for sleep as needed but not exceeding 3 nights per week. Medication regimens must be stable at the time of study enrollment (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). No medications will be started or discontinued for the purpose of enrollment into the study
- Subjects must exhibit no or only moderate alcohol use during study participation. Subjects with current excessive use of alcohol (\> 8 ounces/day) or participants abusing substances will be ineligible for participation, as such drug use could confound the results. A urine toxicology test will be administered at screening to test for drugs of abuse
- Participants exhibiting depression symptoms in the severe range (Ham-D \> 27) will be excluded from participation as an investigational study such as this may not be suitable
- Participants exhibiting chronic MDD episodes (defined as a current episode lasting 5+ years) will be excluded from participation as an investigational study such as this may not be suitable
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2016
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02256566
Start Date
September 1 2014
End Date
April 20 2016
Last Update
July 21 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029