The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/26/2018 |
| Start Date: | January 1, 2018 |
| End Date: | March 1, 2019 |
| Contact: | Neal S Taub, MD |
| Email: | nealtaub@gmail.com |
| Phone: | 7049573391 |
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study
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.
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.
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.
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
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