Depression
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGScopolamine and naltrexone
participants will receive scopolamine and naltrexone in buccal drops
DRUGplacebo arm
participants will receive placebo medications
Sponsors
The Taub Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participants and physician are both blinded to medication vs. control medication
Intervention model description
Double blinded, randomized, controlled parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period | Baseline and 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control(Placebo) Participants will receive placebo medication
placebo arm: participants will receive placebo medications | 6 |
| 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 | 8 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Control(Placebo) | Active(Scopolamine and Naltrexone) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 13 Participants |
| Region of Enrollment United States | 6 participants | 8 participants | 14 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 2 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
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.
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control(Placebo) | Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period | 3.5 units on a scale |
| Active(Scopolamine and Naltrexone) | Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period | 12.5 units on a scale |
p-value: 0.03t-test, 2 sided