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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | Participants will receive placebo medication |
|
| Active | Experimental | participants will receive active medications scopolamine and naltrexone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scopolamine and naltrexone | Drug | participants will receive scopolamine and naltrexone in buccal drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Taub | The Taub Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Taub Group | Charlotte | North Carolina | 28211 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control(Placebo) | Participants will receive placebo medication placebo arm: participants will receive placebo medications |
| FG001 | Active(Scopolamine and Naltrexone) | participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks. Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control(Placebo) | Participants will receive placebo medication placebo arm: participants will receive placebo medications |
| BG001 | Active(Scopolamine and Naltrexone) | participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks. Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 4 weeks |
|
Participants were assessed for adverse events for 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control(Placebo) | Participants will receive placebo medication placebo arm: participants will receive placebo medications |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neal Taub MD | The Taub Group | 7044429805 | nealtaub@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2017 | May 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012601 | Scopolamine |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Double blinded, randomized, controlled parallel design
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The participants and physician are both blinded to medication vs. control medication
| placebo arm | Drug | participants will receive placebo medications |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks. Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Active(Scopolamine and Naltrexone) | participants will receive active medications scopolamine and naltrexone. Scopolamine dose was 0.15mg BID and naltrexone dose was 1mg BID for 4 weeks. Scopolamine and naltrexone: participants will receive scopolamine and naltrexone in buccal drops | 0 | 8 | 0 | 8 | 2 | 8 |
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |