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

NCT00602290 | Completed Phase 4 Results DMC

• 2 other identifiers: R01MH077650DATR A4-GPX
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS) Maintained Scores 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.

  Maintained response measured at Week 16

Secondary Outcomes (1)

• Quality of Life Assessment

  Measured at Baseline and Week 16

Study Arms (3)

1 - Citalopram and placebo

ACTIVE COMPARATOR

Participants will take a combination of citalopram and placebo for 16 weeks

Drug: Citalopram; Drug: Placebo

2 - Methylphenidate and placebo

ACTIVE COMPARATOR

Participants will take a combination of methylphenidate and placebo for 16 weeks

Drug: Methylphenidate (MPH); Drug: Placebo

3 - Methylphenidate and Citalopram

ACTIVE COMPARATOR

Participants will take a combination of methylphenidate and citalopram for 16 weeks

Drug: Citalopram; Drug: Methylphenidate (MPH)

Interventions

Citalopram DRUG

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.

Also known as: Celexa

1 - Citalopram and placebo; 3 - Methylphenidate and Citalopram

Methylphenidate (MPH) DRUG

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.

Also known as: Ritalin

2 - Methylphenidate and placebo; 3 - Methylphenidate and Citalopram

Placebo DRUG

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.

1 - Citalopram and placebo; 2 - Methylphenidate and placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Semel Institute - Neuropsychiatric Institute (NPI)

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Schneider B, Ercoli L, Siddarth P, Lavretsky H. Vascular burden and cognitive functioning in depressed older adults. Am J Geriatr Psychiatry. 2012 Aug;20(8):673-81. doi: 10.1097/JGP.0b013e31822ccd64.

  PMID: 21857219 RESULT

• Eyre HA, Eskin A, Nelson SF, St Cyr NM, Siddarth P, Baune BT, Lavretsky H. Genomic predictors of remission to antidepressant treatment in geriatric depression using genome-wide expression analyses: a pilot study. Int J Geriatr Psychiatry. 2016 May;31(5):510-7. doi: 10.1002/gps.4356. Epub 2015 Oct 15.

  PMID: 26471432 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Citalopram; Methylphenidate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Helen Lavretsky
• Organization: University of California, Los Angeles

hlavretsky@mednet.ucla.edu

310-794-4619

Study Officials

• Helen Lavretsky, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: January 28, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 11, 2018
• Results First Posted: September 1, 2014

Record last verified: 2017-12

Locations

US (1)