Trial Outcomes & Findings for The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression (NCT NCT03386448)
NCT ID: NCT03386448
Last Updated: 2019-05-20
Results Overview
The Montgomery-Asberg (MADRS) depression scale will be utilized throughout the study. The scale is scored 0-60, 0 signifying no depression symptoms and 60 signifying very severe depression. A diagnosis of depression will be given to a participant in this study for a MADRS score of 20 or greater. A clinical response to medication will be noted when a participant has a 25% or greater decrease in MADRS score during the trial.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2019-05-20
Participant Flow
Participant milestones
| Measure |
Control(Placebo)
Participants will receive placebo medication
placebo arm: participants will receive placebo medications
|
Active(Scopolamine and Naltrexone)
participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.
Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Control(Placebo)
Participants will receive placebo medication
placebo arm: participants will receive placebo medications
|
Active(Scopolamine and Naltrexone)
participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.
Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Baseline characteristics by cohort
| Measure |
Control(Placebo)
n=6 Participants
Participants will receive placebo medication
placebo arm: participants will receive placebo medications
|
Active(Scopolamine and Naltrexone)
n=8 Participants
participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.
Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops
|
Total
n=14 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
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksThe Montgomery-Asberg (MADRS) depression scale will be utilized throughout the study. The scale is scored 0-60, 0 signifying no depression symptoms and 60 signifying very severe depression. A diagnosis of depression will be given to a participant in this study for a MADRS score of 20 or greater. A clinical response to medication will be noted when a participant has a 25% or greater decrease in MADRS score during the trial.
Outcome measures
| Measure |
Control(Placebo)
n=6 Participants
Participants will receive placebo medication
placebo arm: participants will receive placebo medications
|
Active(Scopolamine and Naltrexone)
n=6 Participants
participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.
Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops
|
|---|---|---|
|
Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
|
3.5 units on a scale
Interval 1.0 to 7.0
|
12.5 units on a scale
Interval 6.0 to 23.0
|
Adverse Events
Control(Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active(Scopolamine and Naltrexone)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control(Placebo)
n=6 participants at risk
Participants will receive placebo medication
placebo arm: participants will receive placebo medications
|
Active(Scopolamine and Naltrexone)
n=8 participants at risk
participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks.
Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Participants were assessed for adverse events for 8 weeks.
|
25.0%
2/8 • Participants were assessed for adverse events for 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place