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

NCT03386448 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 701
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control

PLACEBO COMPARATOR

Participants will receive placebo medication

Drug: placebo arm

Active

EXPERIMENTAL

participants will receive active medications scopolamine and naltrexone

Drug: Scopolamine and naltrexone

Interventions

Scopolamine and naltrexone DRUG

participants will receive scopolamine and naltrexone in buccal drops

Active

placebo arm DRUG

participants will receive placebo medications

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Taub Group: lead

Study Sites (1)

The Taub Group

Charlotte, North Carolina, 28211, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Scopolamine; Naltrexone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Neal Taub MD
• Organization: The Taub Group

nealtaub@gmail.com

7044429805

Study Officials

• Neal Taub

  The Taub Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants and physician are both blinded to medication vs. control medication
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Double blinded, randomized, controlled parallel design

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: January 1, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: May 20, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)