The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386448
• Other study ID #: 701
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: May 2019
• Source: The Taub Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Scopolamine and naltrexone
participants will receive scopolamine and naltrexone in buccal drops
• placebo arm
participants will receive placebo medications

Locations

Country	Name	City	State
United States	The Taub Group	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Taub Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 4 weeks