Trial Outcomes & Findings for Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression (NCT NCT00781326)
NCT ID: NCT00781326
Last Updated: 2016-09-29
Results Overview
Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
End of Phase I (at 24 weeks)
Results posted on
2016-09-29
Participant Flow
Participant milestones
| Measure |
Open Label Antidepressant
In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
|
|---|---|
|
Phase I
STARTED
|
6
|
|
Phase I
COMPLETED
|
2
|
|
Phase I
NOT COMPLETED
|
4
|
|
Phase 2
STARTED
|
0
|
|
Phase 2
COMPLETED
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Open Label Antidepressant
In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
|
|---|---|
|
Phase I
Adverse Event
|
1
|
|
Phase I
Withdrawal by Subject
|
1
|
|
Phase I
Physician Decision
|
2
|
Baseline Characteristics
Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression
Baseline characteristics by cohort
| Measure |
Open Label Antidepressant
n=6 Participants
In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
Hamilton Depression Rating Scale (24 item)
|
20.5 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Cumulative Illness Rating Scale (Geriatric) total
|
8.3 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: End of Phase I (at 24 weeks)Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.
Outcome measures
| Measure |
Open Label Antidepressant
n=2 Participants
In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.
Placebo: Placebo will be given in doses matching those of nimodipine.
|
|---|---|
|
Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]
|
9.5 units on a scale
Standard Deviation 0.7
|
Adverse Events
Open Label Antidepressant
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Antidepressant
n=6 participants at risk
In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
|
|---|---|
|
Psychiatric disorders
Mania
|
16.7%
1/6 • Number of events 1 • Phase I (at or before 24 weeks)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place