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Phase 4 N=143 Randomized Quadruple-blind Treatment

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

Depression

Enrolled (actual)
143
Serious AEs
0.7%
Results posted
Sep 2014
Primary outcome: Primary: Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16 — 18.3; 18.7; 19.8 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Citalopram (Drug); Methylphenidate (MPH) (Drug); Placebo (Drug)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
University of California, Los Angeles
Primary completion
Jan 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16
18.3; 18.7; 19.8
SECONDARY
Quality of Life Assessment
45.50; 47.06; 47.52; 54.45; 53.54; 57.79

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00602290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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