A Phase 4 interventional study of Scopolamine and naltrexone and placebo arm in Depression, sponsored by The Taub Group. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.
Sponsored by The Taub Group · Phase 4, Interventional, and Treatment
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 14 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with The Taub Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo medication
Drug: placebo arm
participants will receive active medications scopolamine and naltrexone
Drug: Scopolamine and naltrexone
Drug pages: Scopolamine · Naltrexone
participants will receive scopolamine and naltrexone in buccal drops
participants will receive placebo medications
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.
Time frame: Baseline and 4 weeks
| Milestone | Control(Placebo) | Active(Scopolamine and Naltrexone) |
|---|---|---|
| Started | 6 | 8 |
| Completed | 6 | 6 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 2 |
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.
| units on a scale | Control(Placebo) | Active(Scopolamine and Naltrexone) |
|---|---|---|
| Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period | 3.5 (1 to 7) | 12.5 (6 to 23) |
Collected over Participants were assessed for adverse events for 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control(Placebo) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Active(Scopolamine and Naltrexone) | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Event | Control(Placebo) | Active(Scopolamine and Naltrexone) |
|---|---|---|
| NauseaGastrointestinal disorders | 0/6 | 2/8 |
| Age, Categorical(Participants) | Control(Placebo) | Active(Scopolamine and Naltrexone) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 8 | 14 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Control(Placebo) | Active(Scopolamine and Naltrexone) | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Control(Placebo) | Active(Scopolamine and Naltrexone) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 8 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control(Placebo) | Active(Scopolamine and Naltrexone) | Total |
|---|---|---|---|
| United States | 6 | 8 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Nov 2018, 10 months.
Results were first posted in May 2019, 6 months after primary completion.
Of 119 phase 4 interventional studies under Depression, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 59. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Scopolamine · Naltrexone