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Cognitive Training for Depression II

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ClinicalTrials.gov Identifier: NCT01934491
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Cognitive Training A Behavioral: Cognitive Training B Not Applicable

Detailed Description:
There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major MDD, working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 6 weeks of cognitive training sessions, with three sessions per week.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Cognitive Training Intervention for Major Depressive Disorder
Study Start Date : August 2013
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : May 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Training A
emotional memory training exercise
Behavioral: Cognitive Training A
Active Comparator: Cognitive Training B
memory training exercise
Behavioral: Cognitive Training B



Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (Ham-D) [ Time Frame: baseline and week 6 ]
    Depression symptom severity comparison at week 6 to baseline


Secondary Outcome Measures :
  1. Negative Affective Bias [ Time Frame: baseline ]
    scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop

  2. Negative Affective Bias [ Time Frame: week 3 ]
    scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop

  3. Negative Affective Bias [ Time Frame: week 6 ]
    scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop

  4. Working Memory [ Time Frame: baseline ]
    Neurocognition

  5. Working Memory [ Time Frame: week 3 ]
    Neurocognition

  6. Working Memory [ Time Frame: week 6 ]
    Neurocognition



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
  • Age 18-55
  • Able to give informed consent

Exclusion Criteria:

  • A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
  • Visual impairment that would affect the ability to observe the computerized presentation of faces.
  • Motor impairment that would affect the ability to provide a response by quickly pressing a button.
  • Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
  • Primary, current Axis I diagnosis other than Major Depressive Disorder
  • Primary, current Axis II personality disorder.
  • Currently attending a cognitive-behavioral psychotherapy regimen
  • 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.
  • Enrolled participants can be currently taking medication but must be stabilized on their medication regimens before enrolling in the study (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). Accordingly, if a patient's medication status must change during the course of the study, we will discontinue them in the study. We do not anticipate that this will occur frequently, as again, patients' medication regimens must be stable before enrolling in the study. No medications will be discontinued for the purpose of enrollment into the study.

Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (> 8 ounces/day for men and > 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.


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): NCT01934491


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Brian M Iacoviello, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01934491     History of Changes
Other Study ID Numbers: GCO 12-0266
1K23MH099223-01 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
Cognitive training
Depression

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms