The Depression and Memory Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change in scores for the Repeatable Battery for Neuropsychological Status (RBANS) from baseline to 16 weeks.
Study Overview
Brief Summary
The purpose of this study is to determine whether Cymbalta (duloxetine) is effective to improve cognition in individuals with Mild Cognitive Impairment.
Detailed Description
The goal of this study is to conduct a proof of concept clinical trial using antidepressant therapy to improve cognition. This study will utilize a randomized, double blinded, placebo - controlled trial design. The investigators will recruit up to 100 patients. Patients will be screened multiple times to determine eligibility. Patients will be randomized into one of two study groups (placebo control group and Duloxetine group). Patients in the Duloxetine group will receive up to 60 mg of an FDA approved antidepressant, Duloxetine. Patients in the control group will receive a placebo that is the exact shape and size of the study drug. The patients, primary investigators, and research personnel will be blinded to the study condition. The investigators will designate one on-site personnel to serve as data and safety monitor. This person will not be blinded and will randomize patients to condition, work with the pharmacy, and can un-blind condition if necessary.
Potential patients will be invited to a screening visit. This visit is designed to ensure that the patients meet study criteria and that it is safe for them to participate in the study. The screening visit will consist of physical examinations, medical and psychological history, cognitive and functional testing, interviews, questionnaires, research/clinical venipuncture, and a meeting with the study doctor. If a patient is accepted to the trial, he/she will be expected to stay in the study for a minimum of 6 months.
After the screening visit, the study team will meet to determine if the patient will continue to remain in the study. If a patient does remain in the study, he/she will be invited to a randomization visit. Patients will be randomized into either the Duloxetine group or the placebo control group. The data and safety monitor will use a randomization software. This program allows the researcher to enter in the number of subject, and condition, and will generate a table of randomly assigned patients to condition. The patients and study personnel will be blinded to the condition. The data safety monitor will randomly assign patients to condition and work with the pharmacy to properly label the study drugs. Only the data monitoring personnel will be un-blinded and will generate the table of random numbers. After randomization, patients will undergo vitals, interviews, testing, and the study drug will be dispensed to them. First dosage will consist of 30 mg of Duloxetine or placebo, and the participant will be asked to take the first dose at this visit.
Patients will be invited to a 2 week post randomization visit that will consist of a meeting with the study doctor to discuss concerns or side effects. Medication dosage will be raised to 60 mg of Duloxetine or placebo.
Patients will be seen monthly for the next three months. During these visits the patients will receive their study drugs, have their vital signs measured, and be questioned about adverse events or any health changes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Duloxetine group
Active drug group
Intervention: Duloxetine (Drug)
Placebo group
Inactive drug group
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in scores for the Repeatable Battery for Neuropsychological Status (RBANS) from baseline to 16 weeks.
Time Frame: Weeks 0 and 16
RBANS measures immediate memory, visuospatial construction, attention processes and speed of information processing, expressive and receptive language, and delayed memory.
Secondary Outcomes
- Evaluation of the relative dominance of the verbal-reading system from baseline at 16 weeks through the Stroop Color and Word Test(Weeks 0 and 16)
Investigators
Leigh Johnson , PhD, LMSW
Assistant Professor
University of North Texas Health Science Center