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

The Taub Group

Status and phase: Completed; Phase 4

Conditions: Depression

Treatments: Drug: placebo arm; Drug: Scopolamine and naltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03386448

701

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

14 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

Participants will receive placebo medication

Treatment:

Drug: placebo arm

Active

Experimental group

Description:

participants will receive active medications scopolamine and naltrexone

Treatment:

Drug: Scopolamine and naltrexone