DepressionPhase 4NCT03386448

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

A Phase 4 study testing Scopolamine and naltrexone in people with Depression, run by The Taub Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Scopolamine and naltrexone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2018to 20 Nov 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

The Taub Group
Charlotte, North Carolina, 28211

Other trials in United States

About this study

Official title: The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study

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.

Read the 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.

Conditions: Depression
Being tested: Scopolamine and naltrexone, placebo arm
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scopolamine and naltrexoneDrug
participants will receive scopolamine and naltrexone in buccal drops
placebo armDrug
participants will receive placebo medications

Study groups in NCT03386448
Study group	Role	What they receive
control	Placebo comparator	Participants will receive placebo medication Receives: Drug: placebo arm
Active	Experimental	participants will receive active medications scopolamine and naltrexone Receives: Drug: Scopolamine and naltrexone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201820 Nov 2018

First posted29 Dec 2017
Study start1 Jan 2018
Primary completion20 Nov 2018
Study completion20 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double blinded, randomized, controlled parallel design
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03386448
Sponsor's protocol ID: 701
Status last verified: May 2019
First submitted: 21 Dec 2017
Last updated: 20 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study
ClinicalTrials.gov ID: NCT03386448
Acronym / sponsor ID: 701
Conditions: Depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: The Taub GroupIndustry (pharma, biotech, devices)
Study start: 1 Jan 2018 (actual)
Primary completion: 20 Nov 2018 (actual)
Study completion: 20 Nov 2018 (actual)
First posted: 29 Dec 2017 (actual)
Results: Posted 20 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Double blinded, randomized, controlled parallel design

Arm	Type	Receives
control	Placebo comparator	Drug: placebo armParticipants will receive placebo medication
Active	Experimental	Drug: Scopolamine and naltrexoneparticipants will receive active medications scopolamine and naltrexone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

pregnant or lactating
danger to self or others
severe kidney or liver disease
schizophrenia
allergy to scopolamine or naltrexone

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Scopolamine and naltrexoneparticipants will receive scopolamine and naltrexone in buccal drops	Drug	Active
placebo armparticipants will receive placebo medications	Drug	control

Primary outcome

Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
Time frame: 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.

Results and safety

Results posted to the registry on 20 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control(Placebo)	6	6
Active(Scopolamine and Naltrexone)	8	6

Primary outcome: Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period

Time frame: Baseline and 4 weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Control(Placebo) n = 6	Active(Scopolamine and Naltrexone) n = 6
Value	3.5 (1 to 7)	12.5 (6 to 23)

Control(Placebo) vs Active(Scopolamine and Naltrexone): Mean Difference (Final Values): 9.0, p = 0.03, t-test, 2 sided

Adverse events

Time frame: Participants were assessed for adverse events for 8 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control(Placebo)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Active(Scopolamine and Naltrexone)	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neal Taub principal investigator

The Taub Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Scopolamine and naltrexone in people with Depression, run by The Taub Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03386448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.