CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 181 enrolled
Drug / intervention
Citalopram +2 moredrug
Likely dose
Citalopram 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00602290
NCT00602290Phase 4Completed
CompareCT.gov

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

University of California, Los Angeles·interventional·Posted Jan 28, 2008·Updated Jan 11, 2018

In Brief

A Phase 4 clinical trial evaluating Citalopram, Methylphenidate (MPH), and 1 other intervention for Depression. Completed, enrolled 181 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2013
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.4 years ago

Interventions

Citalopramdrug

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.

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.

Placebodrug

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.