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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00602290
First received: January 23, 2008
Last updated: August 28, 2014
Last verified: August 2014
Results First Received: June 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Citalopram
Drug: Methylphenidate (MPH)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
181 participants were enrolled in the study and 38 participants dropped out before randomization. A total of 143 participants were assigned to groups.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    1 - Citalopram + Placebo     2 - Methylphenidate + Placebo     3 - Methylphenidate + Citalopram  
STARTED     48     48     47  
COMPLETED     46     46     46  
NOT COMPLETED     2     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    1 - Citalopram + Placebo     2 - Methylphenidate + Placebo     3 - Methylphenidate + Citalopram     Total  
Number of Participants  
[units: participants]
  48     48     47     143  
Age  
[units: years]
Mean ± Standard Deviation
  70.1  ± 7.1     70.0  ± 7.1     68.9  ± 7.6     69.7  ± 7.3  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     13     17     8     38  
>=65 years     35     31     39     105  
Gender  
[units: participants]
       
Female     31     28     19     78  
Male     17     20     28     65  
Region of Enrollment  
[units: participants]
       
United States     48     48     47     143  



  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16   [ Time Frame: Maintained response measured at Week 16 ]

2.  Secondary:   Quality of Life Assessment   [ Time Frame: Measured at Baseline and Week 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Helen Lavretsky
Organization: University of California, Los Angeles
phone: 310-794-4619
e-mail: hlavretsky@mednet.ucla.edu


Publications of Results:

Responsible Party: Helen Lavretsky, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00602290     History of Changes
Other Study ID Numbers: R01 MH077650, R01MH077650, DATR A4-GPX
Study First Received: January 23, 2008
Results First Received: June 8, 2014
Last Updated: August 28, 2014
Health Authority: United States: Federal Government