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

Phase 4

Completed

• Conditions: Depression
• Interventions: Drug: placebo arm; Drug: Scopolamine and naltrexone

• Registration Number: NCT03386448
• Lead Sponsor: The Taub Group

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.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-28
• Study First Posted: 2017-12-29
• Study Start: 2018-01-01
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Status Verified: 2019-05
• Results First Submitted: 2019-05-10
• Results First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Results First Posted: 2019-05-20
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	placebo arm	Participants will receive placebo medication
Active	Scopolamine and naltrexone	participants will receive active medications scopolamine and naltrexone

Primary Outcome Measures

Name	Time	Method
Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period	Baseline and 4 weeks	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.

Trial Locations

Locations (1)

The Taub Group; 🇺🇸 Charlotte, North Carolina, United States