Phase 4
Completed N=14
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Source: ClinicalTrials.gov NCT03386448 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period — 3.5; 12.5 units on a scale — p=0.03
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period |
3.5; 12.5 | 0.03 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03386448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.