Back to resultsThe Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Scopolamine and naltrexone
placebo arm
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- male or female, aged 18-65
- in good health other than major depression for 8 weeks or more
- negative pregnancy test
- able to comply with instructions
- able to provide informed consent
Exclusion Criteria:
- pregnant or lactating
- danger to self or others
- severe kidney or liver disease
- schizophrenia
- allergy to scopolamine or naltrexone
- glaucoma
- Monoamine oxidase (MAO) inhibitor use
Sites / Locations
- The Taub Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control
Active
Arm Description
Participants will receive placebo medication
participants will receive active medications scopolamine and naltrexone
Outcomes
Primary Outcome Measures
Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03386448
Brief Title
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Official Title
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Taub Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial is to determine the safety and efficacy of scopolamine utilized in conjunction with naltrexone for the treatment of major depression.
Detailed Description
The study will be a double blinded, randomized controlled trial. The medications will be administered orally. The sample size will be 40 participants, 20 in the treatment group and 20 in the control group. The study period will be 4 weeks. Eligible participants will have major depression by history for at least 8 weeks, between 18-65 years old, and in generally good health other than depression. The MADRS questionaire will be utilized to determine the response to the medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, randomized, controlled parallel design
Masking
ParticipantCare Provider
Masking Description
The participants and physician are both blinded to medication vs. control medication
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo medication
Arm Title
Active
Arm Type
Experimental
Arm Description
participants will receive active medications scopolamine and naltrexone
Intervention Type
Drug
Intervention Name(s)
Scopolamine and naltrexone
Intervention Description
participants will receive scopolamine and naltrexone in buccal drops
Intervention Type
Drug
Intervention Name(s)
placebo arm
Intervention Description
participants will receive placebo medications
Primary Outcome Measure Information:
Title
Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
Description
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.
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male or female, aged 18-65
in good health other than major depression for 8 weeks or more
negative pregnancy test
able to comply with instructions
able to provide informed consent
Exclusion Criteria:
pregnant or lactating
danger to self or others
severe kidney or liver disease
schizophrenia
allergy to scopolamine or naltrexone
glaucoma
Monoamine oxidase (MAO) inhibitor use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Taub
Organizational Affiliation
The Taub Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Taub Group
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
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