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Trial Outcomes & Findings for Venlafaxine for Depression in Alzheimer's Disease (DIADs-3) (NCT NCT01609348)

NCT ID: NCT01609348

Last Updated: 2018-01-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-01-31

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
3
2
Overall Study
COMPLETED
3
2
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Venlafaxine
n=3 Participants
225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks
Sugar Pill
n=2 Participants
Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Total
n=5 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure
Venlafaxine
n=3 Participants
225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks
Sugar Pill
n=2 Participants
Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.
Marked improvement according to CGI
2 Participants
0 Participants
Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.
Moderate improvement according to CGI
1 Participants
2 Participants

Adverse Events

Venlafaxine

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Venlafaxine
n=3 participants at risk
225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks
Sugar Pill
n=2 participants at risk
Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Cardiac disorders
Hypokalemia
33.3%
1/3 • Number of events 1
0.00%
0/2

Other adverse events

Other adverse events
Measure
Venlafaxine
n=3 participants at risk
225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks
Sugar Pill
n=2 participants at risk
Placebo: Capsule matching active drug to be taken once a day for 12 weeks
Gastrointestinal disorders
Diarrhea
0.00%
0/3
50.0%
1/2 • Number of events 1
Gastrointestinal disorders
Nausea
33.3%
1/3 • Number of events 1
0.00%
0/2
Cardiac disorders
Low potassium
33.3%
1/3 • Number of events 1
0.00%
0/2

Additional Information

Paul Rosenberg, MD

Johns Hopkins University

Phone: 410-550-9883

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place