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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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Venlafaxine Sugar Pill
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225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks

Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Period Title: Overall Study
Started 3 2
Completed 3 2
Not Completed 0 0
Arm/Group Title Venlafaxine Sugar Pill Total
Hide Arm/Group Description

225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks

Placebo: Capsule matching active drug to be taken once a day for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
2
  66.7%
0
   0.0%
2
  40.0%
Male
1
  33.3%
2
 100.0%
3
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 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%
1.Primary Outcome
Title Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.
Hide Description

Treatment will be considered efficacious if the proportion of worse categories (including 'minimal worsening', 'moderate worsening', or 'marked worsening') is lower under treatment than control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change.

Clinical Global Impression of Change: This is a 7-item score ranging from “markedly worse” to “markedly improved”. It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input

Time Frame 12 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Venlafaxine Sugar Pill
Hide Arm/Group Description:

225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks

Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Overall Number of Participants Analyzed 3 2
Measure Type: Count of Participants
Unit of Measure: Participants
Marked improvement according to CGI
2
  66.7%
0
   0.0%
Moderate improvement according to CGI
1
  33.3%
2
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Venlafaxine Sugar Pill
Hide Arm/Group Description

225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks

Placebo: Capsule matching active drug to be taken once a day for 12 weeks
All-Cause Mortality
Venlafaxine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Venlafaxine Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/2 (0.00%)    
Cardiac disorders     
Hypokalemia   1/3 (33.33%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Venlafaxine Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/2 (50.00%)    
Cardiac disorders     
Low potassium   1/3 (33.33%)  1 0/2 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   0/3 (0.00%)  0 1/2 (50.00%)  1
Nausea   1/3 (33.33%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
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
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