Trial Outcomes & Findings for The Antidepressant Efficacy of the Anticholinergic Scopolamine (NCT NCT00369915)
NCT ID: NCT00369915
Last Updated: 2016-11-10
Results Overview
The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Outcome measures obtained at each of 12 sessions
Results posted on
2016-11-10
Participant Flow
Participant milestones
| Measure |
Plac/Scop
6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
|
Scop/Plac
6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Plac/Scop
6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
|
Scop/Plac
6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
|
|---|---|---|
|
Overall Study
expected side effects
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
W/drawl by investigators
|
0
|
1
|
Baseline Characteristics
The Antidepressant Efficacy of the Anticholinergic Scopolamine
Baseline characteristics by cohort
| Measure |
Plac/Scop
n=10 Participants
6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
|
Scop/Plac
n=7 Participants
6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
33 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
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
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome measures obtained at each of 12 sessionsPopulation: Only participants who completed the trial were included in the analysis.
The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression.
Outcome measures
| Measure |
Plac/Scop
n=4 Participants
6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
|
Scop/Plac
n=4 Participants
6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
|
|---|---|---|
|
Change in Depression Severity
Block 1 - Session 1
|
29.5 units on a scale
Standard Deviation 2.5
|
30.5 units on a scale
Standard Deviation 4.2
|
|
Change in Depression Severity
Block 1 - Session 2
|
26.5 units on a scale
Standard Deviation 8.2
|
29.8 units on a scale
Standard Deviation 1.5
|
|
Change in Depression Severity
Block 1 - Session 3
|
24.5 units on a scale
Standard Deviation 3.7
|
31.0 units on a scale
Standard Deviation 2.9
|
|
Change in Depression Severity
Block 1 - Session 4
|
19.5 units on a scale
Standard Deviation 6.6
|
27.0 units on a scale
Standard Deviation 5.5
|
|
Change in Depression Severity
Block 1 - Session 5
|
19.3 units on a scale
Standard Deviation 7.4
|
27.8 units on a scale
Standard Deviation 5.6
|
|
Change in Depression Severity
Block 1 - Session 6
|
20.8 units on a scale
Standard Deviation 4.5
|
28.5 units on a scale
Standard Deviation 6.2
|
|
Change in Depression Severity
Block 2 - Session 1
|
23.3 units on a scale
Standard Deviation 3.7
|
27.5 units on a scale
Standard Deviation 7.9
|
|
Change in Depression Severity
Block 2 - Session 2
|
18.0 units on a scale
Standard Deviation 3.8
|
23.8 units on a scale
Standard Deviation 6.7
|
|
Change in Depression Severity
Block 2 - Session 3
|
19.8 units on a scale
Standard Deviation 8.3
|
20.0 units on a scale
Standard Deviation 6.5
|
|
Change in Depression Severity
Block 2 - Session 4
|
18 units on a scale
Standard Deviation 9.1
|
17.3 units on a scale
Standard Deviation 9.1
|
|
Change in Depression Severity
Block 2 - Session 5
|
16.3 units on a scale
Standard Deviation 7.9
|
16.8 units on a scale
Standard Deviation 9.7
|
|
Change in Depression Severity
Block 2 - Session 6
|
15.5 units on a scale
Standard Deviation 8.8
|
20.3 units on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Each of 12 sessions.Population: Only study completers were analyzed.
The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety.
Outcome measures
| Measure |
Plac/Scop
n=4 Participants
6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
|
Scop/Plac
n=4 Participants
6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
|
|---|---|---|
|
Hamilton Anxiety Rating Scale
Block 1 - Session 1
|
17.0 units on a scale
Standard Deviation 6.2
|
20.3 units on a scale
Standard Deviation 9.0
|
|
Hamilton Anxiety Rating Scale
Block 1 - Session 2
|
16.8 units on a scale
Standard Deviation 6.2
|
14.5 units on a scale
Standard Deviation 2.7
|
|
Hamilton Anxiety Rating Scale
Block 1 - Session 3
|
14.5 units on a scale
Standard Deviation 8.4
|
14.3 units on a scale
Standard Deviation 4.7
|
|
Hamilton Anxiety Rating Scale
Block 1 - Session 4
|
14.3 units on a scale
Standard Deviation 6.5
|
13.0 units on a scale
Standard Deviation 2.8
|
|
Hamilton Anxiety Rating Scale
Block 1 - Session 5
|
12.8 units on a scale
Standard Deviation 5.0
|
12.0 units on a scale
Standard Deviation 4.7
|
|
Hamilton Anxiety Rating Scale
Block 1 - Session 6
|
17.8 units on a scale
Standard Deviation 7.1
|
11.5 units on a scale
Standard Deviation 5.3
|
|
Hamilton Anxiety Rating Scale
Block 2 - Session 1
|
14.8 units on a scale
Standard Deviation 2.2
|
13.5 units on a scale
Standard Deviation 7.9
|
|
Hamilton Anxiety Rating Scale
Block 2 - Session 2
|
13.3 units on a scale
Standard Deviation 3.8
|
12.0 units on a scale
Standard Deviation 7.6
|
|
Hamilton Anxiety Rating Scale
Block 2 - Session 3
|
14.3 units on a scale
Standard Deviation 4.0
|
13.3 units on a scale
Standard Deviation 5.6
|
|
Hamilton Anxiety Rating Scale
Block 2 - Session 4
|
10.5 units on a scale
Standard Deviation 2.7
|
14.3 units on a scale
Standard Deviation 9.0
|
|
Hamilton Anxiety Rating Scale
Block 2 - Session 5
|
9.8 units on a scale
Standard Deviation 2.1
|
10.3 units on a scale
Standard Deviation 6.0
|
|
Hamilton Anxiety Rating Scale
Block 2 - Session 6
|
11.8 units on a scale
Standard Deviation 3.2
|
11.8 units on a scale
Standard Deviation 6.9
|
Adverse Events
Plac/Scop
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Scop/Plac
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Plac/Scop
n=10 participants at risk
6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
|
Scop/Plac
n=7 participants at risk
6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
|
|---|---|---|
|
Psychiatric disorders
mild confusion
|
10.0%
1/10 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
dry mouth
|
20.0%
2/10 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place