The Use of Methylphenidate to Improve Clinical Outcomes in Geriatric Depression: A Double-blind Placebo-Controlled Trial of Methylphenidate (Ritalin) Augmentation of Citalopram (Celexa) in Depressed Elderly Patients
Overview
- Phase
- Phase 4
- Intervention
- Citalopram
- Conditions
- Depression
- Sponsor
- University of California, Los Angeles
- Enrollment
- 181
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study will evaluate the safety and effectiveness of methylphenidate in improving cognition and function in older adults with depression.
Detailed Description
Less than 50% of older adults with depression achieve remission and functional recovery in response to first-line antidepressant treatment. Most are left with significant residual symptoms, putting them at risk for illness relapse, frailty, and suicide. Improved understanding of the neurobiology of depression in older adults and mechanisms of treatment response may lead to better clinical management of depression. Methylphenidate (MPH) has long been used in the elderly and the medically ill to provide rapid improvement in depression, apathy, and fatigue. However, its potential beneficial effects on cognitive and functional outcomes in older adults with depression have not been studied. Combining MPH with the serotonergic antidepressant citalopram may result in better clinical outcomes than would using citalopram alone. This study will compare the safety and effectiveness of MPH combined with citalopram, MPH combined with placebo, and citalopram combined with placebo in improving thinking, memory, and speed of recovery in older adults with depression. The study will also evaluate selected dopamine- and serotonin-related gene relationships with mood, cognitive symptoms, and treatment response to MPH and citalopram. Participation in this double-blind study will last 16 weeks. All potential participants will initially undergo comprehensive medical, neuropsychiatric, and cognitive assessments and genetic testing. These initial assessments will include questionnaires about depressive symptoms, a medical history, an electrocardiogram (ECG), and a blood draw for the genetic testing. Eligible participants will then be randomly assigned to one of three groups: MPH and citalopram, MPH and placebo, or citalopram and placebo. All participants will receive 16 weeks of treatment with their assigned medications. Study visits will occur weekly for the first 6 weeks of treatment and bi-weekly for the remainder of the study. During study visits, participants will undergo vital sign and weight measurements, answer questionnaires, and report any medication side effects. Blood will again be drawn at Visits 4 and 10, and the ECG will be repeated at Visit 10 if any cardiac symptoms occur. Most initial assessments will be repeated on Visit 13, the last study visit. Participants will also be contacted weekly by phone throughout the study to answer questions on how they are feeling and any possible side effects.
Investigators
Helen Lavretsky, MD
Professor
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Meets Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for major depressive disorder (recurrent and nonrecurrent course will be identified)
- •Score of 16 or higher on the 24-item Hamilton Depression Rating Scale (HDRS) at study entry
- •Score of 26 or higher on the Mini-Mental State Exam (MMSE)
Exclusion Criteria
- •History of psychiatric illness or a substance abuse disorder other than unipolar depression, diagnosed prior to the onset of the first depressive episode
- •Presence of psychotic symptoms
- •Severe or acute medical illness (e.g., major surgery, metastatic cancer, stroke, heart attack) 6 months prior to study entry
- •Acute suicidal or violent behavior or history of suicide attempt within the year prior to study entry
- •Presence of delirium, neurodegenerative dementia, Parkinson's disease, or any other central nervous system (CNS) diseases
- •Toxic or metabolic abnormalities on laboratory examination
- •Medications taken or medical illnesses present that could account for depression
- •Active heart failure categorized as Class III or greater according to New York Heart Association criteria
- •Heart attack or crescendo angina within the 3 months prior to study entry
- •Symptomatic cardiac arrhythmias or symptomatic, hemodynamically significant mitral or aortic valvular disease
Arms & Interventions
1 - Citalopram and placebo
Participants will take a combination of citalopram and placebo for 16 weeks
Intervention: Citalopram
1 - Citalopram and placebo
Participants will take a combination of citalopram and placebo for 16 weeks
Intervention: Placebo
2 - Methylphenidate and placebo
Participants will take a combination of methylphenidate and placebo for 16 weeks
Intervention: Methylphenidate (MPH)
2 - Methylphenidate and placebo
Participants will take a combination of methylphenidate and placebo for 16 weeks
Intervention: Placebo
3 - Methylphenidate and Citalopram
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Intervention: Citalopram
3 - Methylphenidate and Citalopram
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Intervention: Methylphenidate (MPH)
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16
Time Frame: Maintained response measured at Week 16
The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less.
Secondary Outcomes
- Quality of Life Assessment(Measured at Baseline and Week 16)