Effectiveness of Methylphenidate in Improving Cognition and Function in Older Adults With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Citalopram; Methylphenidate (MPH); Placebo
Intervention description: Citalopram dosage will be 20 to 60 mg a day prior to FDA warning limiting it to 20-40 mg in 2011. Participants will begin taking one 20-mg capsule once per day for 4 weeks, and this dosage may be increased or decreased depending on the participant's response to the medication or side-effect profile. Participants will continue on their assigned dosage of citalopram that will be titrated up after week 4 if clinical global impressions (CGI) scores were > 2 until treatment completion.; MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule (2.5 mg) twice per day, which will be increased to a maximum up to 8 x 2.5 mg capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.; 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 16 capsules twice per day matching methylphenidate, and 1-3 capsules matching citalopram. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Intervention MeSH terms: Methylphenidate; Citalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Major Depression; Geriatric Major Unipolar Depression; Executive Cognitive Dysfunction; Elderly; Geriatric; Executive Cognitive Impairment; Quality of Life; Disability; Comorbidity; Medical Burden; Safety; Candidate Genes

Summary:

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

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

          -  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