Citalopram for Agitation in Alzheimer's Disease (CitAD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dave Shade, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00898807
First received: May 11, 2009
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: March 19, 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
Conditions: Alzheimer's Disease
Agitation
Interventions: Drug: citalopram
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
Recruitment activities included chart review, telephone interviews and screens, discussion with physicians, and recruitment in the clinic waiting areas and assisted living facilities affiliated with the clinics. The recruitment period lasted from August 2009 to December 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Citalopram and Psychosocial Intervention

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

citalopram : target dose 30mg daily for 9 weeks

Placebo and Psychosocial Intervention

Matching placebo, oral, and psychosocial intervention

placebo : daily for 9 weeks


Participant Flow:   Overall Study
    Citalopram and Psychosocial Intervention     Placebo and Psychosocial Intervention  
STARTED     94     92  
COMPLETED     86     83  
NOT COMPLETED     8     9  
Withdrawal by Subject                 5                 3  
Family pressure to discontinue                 2                 2  
Lost to Follow-up                 1                 3  
Death                 0                 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
Citalopram and Psychosocial Intervention

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

citalopram : target dose 30mg daily for 9 weeks

Placebo and Psychosocial Intervention

Matching placebo, oral, and psychosocial intervention

placebo : daily for 9 weeks

Total Total of all reporting groups

Baseline Measures
    Citalopram and Psychosocial Intervention     Placebo and Psychosocial Intervention     Total  
Number of Participants  
[units: participants]
  94     92     186  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     7     13  
>=65 years     88     85     173  
Age  
[units: years]
Mean ± Standard Deviation
  78  ± 9     79  ± 8     78  ± 8  
Gender  
[units: participants]
     
Female     44     41     85  
Male     50     51     101  
Region of Enrollment  
[units: participants]
     
United States     82     79     161  
Canada     12     13     25  



  Outcome Measures
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1.  Primary:   NeuroBehavior Rating Scale-- Agitation   [ Time Frame: 9 weeks ]

2.  Primary:   Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)   [ Time Frame: Baseline to 9 weeks ]

3.  Secondary:   Cohen-Mansfield Agitation Inventory (CMAI)   [ Time Frame: 9 weeks ]

4.  Secondary:   Neuropsychiatric Inventory (NPI)-- Agitation Subscore   [ Time Frame: 9 weeks ]


  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: Anne Casper
Organization: Johns Hopkins
phone: 410-955-8183
e-mail: ashankl1@jhu.edu


Publications of Results:
Other Publications:

Responsible Party: Dave Shade, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00898807     History of Changes
Other Study ID Numbers: IA0155, R01AG031348
Study First Received: May 11, 2009
Results First Received: March 19, 2014
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board