Trial Outcomes & Findings for Effectiveness of Methylphenidate in Improving Cognition and Function in Older Adults With Depression (NCT NCT00602290)
NCT ID: NCT00602290
Last Updated: 2018-01-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
181 participants
Primary outcome timeframe
Maintained response measured at Week 16
Results posted on
2018-01-11
Participant Flow
181 participants were enrolled in the study and 38 participants dropped out before randomization. A total of 143 participants were assigned to groups.
Participant milestones
| Measure |
1 - Citalopram + Placebo
Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2 - Methylphenidate + Placebo
Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 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: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3 - Methylphenidate + Citalopram
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
47
|
|
Overall Study
COMPLETED
|
46
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Methylphenidate in Improving Cognition and Function in Older Adults With Depression
Baseline characteristics by cohort
| Measure |
1 - Citalopram + Placebo
n=48 Participants
Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2 - Methylphenidate + Placebo
n=48 Participants
Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 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: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3 - Methylphenidate + Citalopram
n=47 Participants
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Age, Continuous
|
70.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
47 participants
n=5 Participants
|
143 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Maintained response measured at Week 16The 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.
Outcome measures
| Measure |
1 - Citalopram + Placebo
n=48 Participants
Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2 - Methylphenidate + Placebo
n=48 Participants
Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 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: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3 - Methylphenidate + Citalopram
n=47 Participants
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
|
|---|---|---|---|
|
Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16
|
18.3 units on a scale
Standard Deviation 5.2 • Interval 0.0 to 76.0
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18.7 units on a scale
Standard Deviation 5.1 • Interval 0.0 to 76.0
|
19.8 units on a scale
Standard Deviation 6.3 • Interval 0.0 to 76.0
|
SECONDARY outcome
Timeframe: Measured at Baseline and Week 16Population: The overall analyzed at baseline and week 16 differs due to participant drop out.
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.
Outcome measures
| Measure |
1 - Citalopram + Placebo
n=48 Participants
Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2 - Methylphenidate + Placebo
n=47 Participants
Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 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: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3 - Methylphenidate + Citalopram
n=48 Participants
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
|
|---|---|---|---|
|
Quality of Life Assessment
Week 16
|
54.45 units on a scale
Standard Deviation 7.54
|
53.54 units on a scale
Standard Deviation 13.11
|
57.79 units on a scale
Standard Deviation 9.19
|
|
Quality of Life Assessment
Baseline
|
45.50 units on a scale
Standard Deviation 7.59
|
47.06 units on a scale
Standard Deviation 8.43
|
47.52 units on a scale
Standard Deviation 7.32
|
Adverse Events
1 - Citalopram + Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
2 - Methylphenidate + Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
3 - Methylphenidate + Citalopram
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 - Citalopram + Placebo
n=48 participants at risk
Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2 - Methylphenidate + Placebo
n=48 participants at risk
Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 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: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3 - Methylphenidate + Citalopram
n=47 participants at risk
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
|
|---|---|---|---|
|
Renal and urinary disorders
death
|
2.1%
1/48
|
0.00%
0/48
|
0.00%
0/47
|
Other adverse events
| Measure |
1 - Citalopram + Placebo
n=48 participants at risk
Participants will take a combination of citalopram and placebo for 16 weeks
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
Placebo: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
2 - Methylphenidate + Placebo
n=48 participants at risk
Participants will take a combination of methylphenidate and placebo for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 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: 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. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
|
3 - Methylphenidate + Citalopram
n=47 participants at risk
Participants will take a combination of methylphenidate and citalopram for 16 weeks
Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.
|
|---|---|---|---|
|
Gastrointestinal disorders
Reduced salivation
|
6.2%
3/48
|
18.8%
9/48
|
8.5%
4/47
|
Additional Information
Dr. Helen Lavretsky
University of California, Los Angeles
Phone: 310-794-4619
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place