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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-11-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, randomized, controlled parallel design

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The participants and physician are both blinded to medication vs. control medication

Study Groups

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control

Participants will receive placebo medication

Group Type PLACEBO_COMPARATOR

placebo arm

Intervention Type DRUG

participants will receive placebo medications

Active

participants will receive active medications scopolamine and naltrexone

Group Type EXPERIMENTAL

Scopolamine and naltrexone

Intervention Type DRUG

participants will receive scopolamine and naltrexone in buccal drops

Interventions

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Scopolamine and naltrexone

participants will receive scopolamine and naltrexone in buccal drops

Intervention Type DRUG

placebo arm

participants will receive placebo medications

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes