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

Study Overview
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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.

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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: Scopolamine and naltrexone
* Drug: placebo arm


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded, randomized, controlled parallel design
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |