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

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ClinicalTrials.gov Identifier: NCT03386448
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Scopolamine and naltrexone Drug: placebo arm Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, randomized, controlled parallel design
Masking: Double (Participant, Care Provider)
Masking Description: The participants and physician are both blinded to medication vs. control medication
Primary Purpose: Treatment
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
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : March 1, 2019


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. response to medications [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386448


Contacts
Contact: Neal S Taub, MD 7049573391 nealtaub@gmail.com
Contact: Shelley H Hagerty, BA 7044429805 shagerty@taubmd.com

Locations
United States, North Carolina
The Taub Group Recruiting
Charlotte, North Carolina, United States, 28211
Contact: Neal Taub    704-957-3391    nealtaub@gmail.com   
Contact: Shelley Hagerty    7044429805    shagerty@taubmd.com   
Sponsors and Collaborators
The Taub Group
Investigators
Principal Investigator: Neal Taub The Taub Group
More Information

Responsible Party: Neal Taub, Principle Investigator, The Taub Group
ClinicalTrials.gov Identifier: NCT03386448     History of Changes
Other Study ID Numbers: 701
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Naltrexone
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics