NCT01934491

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3.8 years

First QC Date

August 29, 2013

Last Update Submit

July 19, 2017

Conditions

Major Depressive Disorder

Keywords

Cognitive trainingDepression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (Ham-D)

    Depression symptom severity comparison at week 6 to baseline

    baseline and week 6

Secondary Outcomes (6)

  • Negative Affective Bias

    baseline

  • Negative Affective Bias

    week 3

  • Negative Affective Bias

    week 6

  • Working Memory

    baseline

  • Working Memory

    week 3

  • +1 more secondary outcomes

Study Arms (2)

Cognitive Training A

EXPERIMENTAL

emotional memory training exercise

Behavioral: Cognitive Training A

Cognitive Training B

ACTIVE COMPARATOR

memory training exercise

Behavioral: Cognitive Training B

Interventions

Cognitive Training ABEHAVIORAL
Cognitive Training A
Cognitive Training BBEHAVIORAL
Cognitive Training B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Brian M Iacoviello, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 4, 2013

Study Start

August 1, 2013

Primary Completion

May 16, 2017

Study Completion

May 16, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)