Title
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study
Phase
Phase 4Lead Sponsor
The Taub GroupStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
DepressionIntervention/Treatment
Scopolamine and naltrexone [scopolamine (65656), naltrexone (33103)] ...Study Participants
14The 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.
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.
participants will receive scopolamine and naltrexone in buccal drops
participants will receive placebo medications
participants will receive active medications scopolamine and naltrexone
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
| Event Type | Organ System | Event Term | Control(Placebo) | Active(Scopolamine and Naltrexone) |
|---|
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.
