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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01748032
Other study ID # 12-28
Secondary ID
Status Terminated
Phase N/A
First received December 10, 2012
Last updated April 6, 2016
Start date August 2012
Est. completion date September 2014

Study information

Verified date April 2016
Source Rotman Research Institute at Baycrest
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of the alternative uses training (AUT) and word association training (WAT) on cognitive functions and mood symptoms in late-life depression (LLD).

The hypotheses are:

1. post-training cognitive performance will be superior to pre-training cognitive performance

2. post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and

3. AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date September 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Male or female

- Age >=55

- Proficiency in English

- Current depressive episode and meet criteria for DSM-IV major depressive disorder

- Hamilton Depression Rating Scale score >=15

- Able to give informed consent

- Stable medication dosages during the training period

Exclusion Criteria:

- Other DSM-IV Axis I psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders

- Mini-Mental State Examination score of <26

- Diagnosis of dementia

- Neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer)

- Unstable medical illnesses requiring active treatment

- Vision or hearing impairment affecting ability to participate in training

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive training
20 minutes/day for 5 sequential working days

Locations

Country Name City State
Canada Rotman Research Institute at Baycrest Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Rotman Research Institute at Baycrest Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed Computerized Executive Tasks:
Number-Letter Task
Letter-Memory Task
Stroop Task
Non-Computerized Measures:
Cattell Culture Fair Intelligence Test
Mattis Dementia Rating Scale-2 (DRS-2)
Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day No
Secondary Changes in mood including depression, anxiety and apathy Montgomery Asberg Depression Rating Scale (MADRS)
Apathy Evaluation Scale (AES)
Hamilton Anxiety Rating Scale (Ham-A)
Beck Depression Inventory (BDI)
Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day No
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