Depression Clinical Trial
— DEMOOfficial title:
The Depression and Memory Trial
Verified date | October 2018 |
Source | University of North Texas Health Science Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether Cymbalta (duloxetine) is effective to improve cognition in individuals with Mild Cognitive Impairment.
Status | Completed |
Enrollment | 19 |
Est. completion date | October 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Male or female, age 50 and up. - Female participants must be post-menopausal for at least two consecutive years. - Health and Aging Brain Study participant, who provided consent for re-contact - Diagnosis of MCI (by Health and Aging Brain Study Consensus Review). - Has an elevated DepE score (2 or more). This is calculated by summing scores for five items (Items 14, 16, 17,25 &26) on the Geriatric Depression Scale. Exclusion Criteria: - Inability to provide informed consent by self or by proxy. - Pregnant or breast feeding women - Uncontrolled narrow angle glaucoma - Known hypersensitivity to duloxetine. - Participation in a Clinical Trial in the last three months. - Other psychiatric disorder like bipolar disorder, schizophrenia, or dementia. - Use of antidepressants, anti-psychotics, and mood stabilizers. - History of stroke. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Texas Health Science Center | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
University of North Texas Health Science Center |
United States,
Johnson LA, Hall JR, O'Bryant SE. A depressive endophenotype of mild cognitive impairment and Alzheimer's disease. PLoS One. 2013 Jul 11;8(7):e68848. doi: 10.1371/journal.pone.0068848. Print 2013. — View Citation
Johnson LA, Mauer C, Jahn D, Song M, Wyshywaniuk L, Hall JR, Balldin VH, O'Bryant SE. Cognitive differences among depressed and non-depressed MCI participants: a project FRONTIER study. Int J Geriatr Psychiatry. 2013 Apr;28(4):377-82. doi: 10.1002/gps.3835. Epub 2012 May 31. — View Citation
Johnson LA, Sohrabi HR, Hall JR, Kevin T, Edwards M, O'Bryant SE, Martins RN. A depressive endophenotype of poorer cognition among cognitively healthy community-dwelling adults: results from the Western Australia memory study. Int J Geriatr Psychiatry. 2015 Aug;30(8):881-6. doi: 10.1002/gps.4231. Epub 2014 Nov 13. — View Citation
O'Bryant SE, Johnson L, Balldin V, Edwards M, Barber R, Williams B, Devous M, Cushings B, Knebl J, Hall J. Characterization of Mexican Americans with mild cognitive impairment and Alzheimer's disease. J Alzheimers Dis. 2013;33(2):373-9. doi: 10.3233/JAD-2012-121420. — View Citation
O'Bryant SE, Johnson L, Reisch J, Edwards M, Hall J, Barber R, Devous MD Sr, Royall D, Singh M. Risk factors for mild cognitive impairment among Mexican Americans. Alzheimers Dement. 2013 Nov;9(6):622-631.e1. doi: 10.1016/j.jalz.2012.12.007. Epub 2013 May 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in scores for the Repeatable Battery for Neuropsychological Status (RBANS) from baseline to 16 weeks. | RBANS measures immediate memory, visuospatial construction, attention processes and speed of information processing, expressive and receptive language, and delayed memory. | Weeks 0 and 16 | |
Secondary | Evaluation of the relative dominance of the verbal-reading system from baseline at 16 weeks through the Stroop Color and Word Test | The Stroop is associated with cognitive flexibility, resistance to interference from outside stimuli, creativity, and psychopathology | Weeks 0 and 16 |
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