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

The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: placebo arm; Drug: Scopolamine and naltrexone

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • The Taub Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; Participants will receive placebo medication	Drug: placebo arm; participants will receive placebo medications
Experimental: Active; participants will receive active medications scopolamine and naltrexone	Drug: Scopolamine and naltrexone; participants will receive scopolamine and naltrexone in buccal drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Taub Group
• Investigators: Principal Investigator: Neal Taub, The Taub Group

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Sensory System Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Narcotic Antagonists; Alcohol Deterrents; Mydriatics; Naltrexone; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: 701 (Registry Identifier: RSO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No