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Completed

NCT Number: NCT03386448

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Taub Group

Charlotte, North Carolina, 28211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scopolamine and naltrexone

Drug

participants will receive scopolamine and naltrexone in buccal drops

Placebo arm

Drug

participants will receive placebo medications

Primary outcomes

  1. Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Taub Group

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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