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Depression in Alzheimer's Disease-2 (DIADS-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086138
First Posted: June 28, 2004
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Constantine G. Lyketsos, Johns Hopkins University
Results First Submitted: March 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alzheimer's Disease
Depression
Interventions: Drug: Sertraline (Zoloft)
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
Participants were recruited from memory clinics at five academic centers in the United States.

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
Placebo

Participants will receive placebo matched to sertraline

Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks

Sertraline

Participants will receive sertraline at a target dose of 100mg daily.

Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks


Participant Flow:   Overall Study
    Placebo   Sertraline
STARTED   64   67 
COMPLETED   60   64 
NOT COMPLETED   4   3 



  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
Sertraline

Participants will receive sertraline at a target dose of 100mg daily.

Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks

Placebo

Participants will receive placebo matched to sertraline

Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks

Total Total of all reporting groups

Baseline Measures
   Sertraline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   64   131 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
     
Age   76.5  (8)   78.2  (8)   77.3  (8) 
Sex/Gender, Customized 
[Units: Participants]
     
Female   40   31   71 
Male   27   33   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)   [ Time Frame: Measured at Week 12 ]

2.  Secondary:   Remission According to Cornell Scale for Depression in Dementia Scale   [ Time Frame: Measured at Weeks 12 ]


  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
No text entered.


  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: Paul Rosenberg
Organization: JHU
phone: 410-550-9883
e-mail: prosenb9@jhmi.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Constantine G. Lyketsos, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00086138     History of Changes
Other Study ID Numbers: U01MH066136 ( U.S. NIH Grant/Contract )
DATR A4-GPX
First Submitted: June 25, 2004
First Posted: June 28, 2004
Results First Submitted: March 8, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017