Effectiveness of Methylphenidate in Improving Cognition and Function in Older Adults With Depression

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and effectiveness of methylphenidate in improving cognition and function in older adults with depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Citalopram; Dexetimide; Methylphenidate

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

• Resting heart rate less than 50 beats per minute and a corrected QT (QTc) interval greater than 0.45 seconds

• Second or third degree atrioventricular block

• Systolic blood pressure greater than 180 mmHg or less than 90 mmHg and diastolic blood pressure greater than 105 mmHg or less than 50 mmHg at study entry

• Treated with depot neuroleptic therapy within 6 months prior to study entry

• Treated with any neuroleptic, antidepressant, anxiolytic medication (other than lorazepam), or over-the-counter CNS-active medications used for treatment of depression (e.g, St. John's Wort, kava-kava, melatonin) within 2 weeks (4 weeks for fluoxetine or monoamine-oxidase inhibitors (MAOIs)) prior to the first administration of study medication

• Known allergy to citalopram or MPH or history of ineffective treatment with citalopram or MPH for current depressive episode

• Requires concomitant therapy with any prescription or over-the-counter medications that have potentially dangerous interactions with either citalopram or MPH

• Requires electroconvulsive therapy (ECT) or received ECT within 3 months prior to study entry

• Initiated psychotherapy within 3 months prior to study entry or will be initiating or terminating psychotherapy during the study