Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00602290 |
This study will evaluate the safety and effectiveness of methylphenidate in improving cognition and function in older adults with depression.
Condition | Intervention | Phase |
---|---|---|
Depression |
Drug: Citalopram Drug: Methylphenidate (MPH) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 168 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Participants will take a combination of citalopram and methylphenidate for 16 weeks
|
Drug: Citalopram
Citalopram dosage will be 10 to 40 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Drug: Methylphenidate (MPH)
MPH dosage will be 5 to 30 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 12 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2: Active Comparator
Participants will take a combination of citalopram and placebo for 16 weeks
|
Drug: Citalopram
Citalopram dosage will be 10 to 40 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Drug: Placebo
Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 12 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3: Active Comparator
Participants will take a combination of methylphenidate and placebo for 16 weeks
|
Drug: Methylphenidate (MPH)
MPH dosage will be 5 to 30 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 12 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Drug: Placebo
Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 12 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
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. 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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Helen Lavretsky, MD | 310-794-4619 | hlavrets@ucla.edu |
United States, California | |
UCLA Semel Institute - Neuropsychiatric Institute (NPI) | Recruiting |
Los Angeles, California, United States, 90095 | |
Principal Investigator: Helen Lavretsky, MD |
Principal Investigator: | Helen Lavretsky, MD | University of California, Los Angeles |
Responsible Party: | UCLA ( Helen Lavretsky ) |
Study ID Numbers: | R01 MH077650, DATR A4-GPX |
Study First Received: | January 23, 2008 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00602290 |
Health Authority: | United States: Federal Government |
Major Depression Geriatric Major Unipolar Depression Executive Cognitive Dysfunction Elderly Geriatric Executive Cognitive Impairment |
Quality of Life Disability Comorbidity Medical Burden Safety Candidate Genes |
Dopamine Depression Mental Disorders Mood Disorders Methylphenidate Quality of Life |
Depressive Disorder, Major Dexetimide Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Central Nervous System Stimulants Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |