A Phase 4 interventional study of Citalopram and Methylphenidate (MPH) in Depression, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Treatment
This study will evaluate the safety and effectiveness of methylphenidate in improving cognition and function in older adults with depression.
Less than 50% of older adults with depression achieve remission and functional recovery in response to first-line antidepressant treatment. Most are left with significant residual symptoms, putting them at risk for illness relapse, frailty, and suicide. Improved understanding of the neurobiology of depression in older adults and mechanisms of treatment response may lead to better clinical management of depression. Methylphenidate (MPH) has long been used in the elderly and the medically ill to provide rapid improvement in depression, apathy, and fatigue. However, its potential beneficial effects on cognitive and functional outcomes in older adults with depression have not been studied. Combining MPH with the serotonergic antidepressant citalopram may result in better clinical outcomes than would using citalopram alone. This study will compare the safety and effectiveness of MPH combined with citalopram, MPH combined with placebo, and citalopram combined with placebo in improving thinking, memory, and speed of recovery in older adults with depression. The study will also evaluate selected dopamine- and serotonin-related gene relationships with mood, cognitive symptoms, and treatment response to MPH and citalopram.
Participation in this double-blind study will last 16 weeks. All potential participants will initially undergo comprehensive medical, neuropsychiatric, and cognitive assessments and genetic testing. These initial assessments will include questionnaires about depressive symptoms, a medical history, an electrocardiogram (ECG), and a blood draw for the genetic testing. Eligible participants will then be randomly assigned to one of three groups: MPH and citalopram, MPH and placebo, or citalopram and placebo. All participants will receive 16 weeks of treatment with their assigned medications. Study visits will occur weekly for the first 6 weeks of treatment and bi-weekly for the remainder of the study. During study visits, participants will undergo vital sign and weight measurements, answer questionnaires, and report any medication side effects. Blood will again be drawn at Visits 4 and 10, and the ECG will be repeated at Visit 10 if any cardiac symptoms occur. Most initial assessments will be repeated on Visit 13, the last study visit. Participants will also be contacted weekly by phone throughout the study to answer questions on how they are feeling and any possible side effects.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 181 is above the median of 84 across 6,869 interventional studies indexed under Depression.
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Exclusion Criteria:
Participants will take a combination of citalopram and placebo for 16 weeks
Drug: Citalopram · Drug: Placebo
Participants will take a combination of methylphenidate and placebo for 16 weeks
Drug: Methylphenidate (MPH) · Drug: Placebo
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Drug: Citalopram · Drug: Methylphenidate (MPH)
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
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
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.
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.
Time frame: Maintained response measured at Week 16
Quality of Life Assessment
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The total score is reported for items 1-14. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with higher values representing a better outcome.
Time frame: Measured at Baseline and Week 16
| Milestone | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram |
|---|---|---|---|
| Started | 48 | 48 | 47 |
| Completed | 46 | 46 | 46 |
| Not completed | 2 | 2 | 1 |
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.
| units on a scale | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram |
|---|---|---|---|
| Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16 | 18.3 ± 5.2 | 18.7 ± 5.1 | 19.8 ± 6.3 |
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The total score is reported for items 1-14. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with higher values representing a better outcome.
| units on a scale | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram |
|---|---|---|---|
| Baseline | 45.50 ± 7.59 | 47.06 ± 8.43 | 47.52 ± 7.32 |
| Week 16 | 54.45 ± 7.54 | 53.54 ± 13.11 | 57.79 ± 9.19 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 - Citalopram + Placebo | — | 1/48 (2.1%) | 3/48 (6.3%) |
| 2 - Methylphenidate + Placebo | — | 0/48 (0%) | 9/48 (18.8%) |
| 3 - Methylphenidate + Citalopram | — | 0/47 (0%) | 4/47 (8.5%) |
| Event | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram |
|---|---|---|---|
| deathRenal and urinary disorders | 1/48 | 0/48 | 0/47 |
| Event | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram |
|---|---|---|---|
| Reduced salivationGastrointestinal disorders | 3/48 | 9/48 | 4/47 |
| Age, Continuous(years) | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram | Total |
|---|---|---|---|---|
| Mean | 70.1 ± 7.1 | 70.0 ± 7.1 | 68.9 ± 7.6 | 69.7 ± 7.3 |
| Age, Categorical(Participants) | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 17 | 8 | 38 |
| >=65 years | 35 | 31 | 39 | 105 |
| Sex: Female, Male(Participants) | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram | Total |
|---|---|---|---|---|
| Female | 31 | 28 | 19 | 78 |
| Male | 17 | 20 | 28 | 65 |
| Region of Enrollment(participants) | 1 - Citalopram + Placebo | 2 - Methylphenidate + Placebo | 3 - Methylphenidate + Citalopram | Total |
|---|---|---|---|---|
| United States | 48 | 48 | 47 | 143 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Citalopram · Methylphenidate
University of California, Los Angeles →