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Venlafaxine for Depression in Alzheimer's Disease (DIADs-3) (DIADs-3)

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ClinicalTrials.gov Identifier: NCT01609348
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Alzheimer's Disease
Depression
Interventions: Drug: Placebo
Drug: Venlafaxine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Venlafaxine

225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks

Sugar Pill Placebo: Capsule matching active drug to be taken once a day for 12 weeks

Participant Flow:   Overall Study
    Venlafaxine   Sugar Pill
STARTED   3   2 
COMPLETED   3   2 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Venlafaxine

225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks

Sugar Pill Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Venlafaxine   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   2   5 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      1  50.0%      1  20.0% 
>=65 years      3 100.0%      1  50.0%      4  80.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  66.7%      0   0.0%      2  40.0% 
Male      1  33.3%      2 100.0%      3  60.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  33.3%      0   0.0%      1  20.0% 
White      2  66.7%      2 100.0%      4  80.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Rosenberg, MD
Organization: Johns Hopkins University
phone: 410-550-9883
e-mail: prosenb9@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01609348     History of Changes
Other Study ID Numbers: NA_00066043
First Submitted: April 27, 2012
First Posted: June 1, 2012
Results First Submitted: October 16, 2017
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018