Trial Outcomes & Findings for Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing (NCT NCT04650217)

Last Updated: 2023-02-02

Results Overview

The MADRS is a standard rater-administered measure of depression severity that will be used to measure changes in depressive symptoms during the study. The total MADRS score ranges from a minimum score of 0 to a maximum score of 60. Higher scores indicate more severe depression.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Week 0 (Baseline)

Results posted on

2023-02-02

Participant Flow

Only 1 participant signed consent to participate, but no one was randomized in the study.

Participant milestones

Participant milestones
Measure	L-DOPA + Exercise Study terminated, no subjects recruited for this arm.	LDOPA + Control Study terminated, no subjects recruited for this arm.	Placebo + Exercise Study terminated, no subjects recruited for this arm.	Placebo + Control Study terminated, no subjects recruited for this arm.	Non-randomized Participants Participants who signed informed consent for the study but were never randomized
Overall Study STARTED	0	0	0	0	1
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	L-DOPA + Exercise Study terminated, no subjects recruited for this arm.	LDOPA + Control Study terminated, no subjects recruited for this arm.	Placebo + Exercise Study terminated, no subjects recruited for this arm.	Placebo + Control Study terminated, no subjects recruited for this arm.	Non-randomized Participants n=1 Participants Participants who signed consent but were not randomized	Total n=1 Participants Total of all reporting groups
Age, Customized Age	—	—	—	—	66 years n=21 Participants	66 years n=10 Participants
Sex: Female, Male Female	—	—	—	—	1 Participants n=21 Participants	1 Participants n=10 Participants
Sex: Female, Male Male	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	—	—	1 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	—	—	—	—	1 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) More than one race	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	—	—	—	—	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	—	—	—	—	1 participants n=21 Participants	1 participants n=10 Participants

PRIMARY outcome

Timeframe: Week 0 (Baseline)

Population: 1 participant signed consent to participate in the study but was never randomized to a study group.