Major Depressive DisorderPhase 2ASCENDNCT03595579

Assessing Symptomatic Clinical Episodes in Depression

A Phase 2 study testing AXS-05 and Bupropion in people with Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 4 sites 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

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: AXS-05 and Bupropion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 4 sitesUnited States
Study dates: 30 May 2018to 7 Jan 2019
Phase: Phase 2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Currently meets DSM-5 criteria for MDD
Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

Who cannot join

Suicide risk
History of treatment resistance in current depressive episode
History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Additional criteria may apply

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Clinical Research Site
Bellevue, Washington, 98007
Clinical Research Site
Beverly Hills, California, 90210
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Orlando, Florida, 32801

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Read the detailed description

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Conditions: Major Depressive Disorder
Being tested: AXS-05, Bupropion
Keywords: AXS-05, Major Depressive Disorder, MDD, Axsome, Depression, Dextromethorphan, Bupropion, Sigma-1, NDMA, ASCEND
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

AXS-05Drug
AXS-05 taken twice daily for 6 weeks.
BupropionDrug
Bupropion taken twice daily for 6 weeks.

Study groups in NCT03595579
Study group	Role	What they receive
AXS-05	Experimental	Not described Receives: Drug: AXS-05
Bupropion	Active comparator	Not described Receives: Drug: Bupropion

What is being measured

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

MADRS Score - Overall Change From Baseline
The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Measured: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)

Timeline

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

30 May 20187 Jan 2019

First posted23 Jul 2018
Study start30 May 2018
Primary completion7 Jan 2019
Study completion7 Jan 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03595579
Sponsor's protocol ID: AXS-05-MDD-201
Acronym: ASCEND
Status last verified: Sep 2021
First submitted: 20 Jun 2018
Last updated: 24 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: via publication

Publications

Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18.
PubMed 35582785

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?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder
ClinicalTrials.gov ID: NCT03595579
Acronym / sponsor ID: ASCEND / AXS-05-MDD-201
Conditions: Major Depressive Disorder
Keywords: AXS-05, Major Depressive Disorder, MDD, Axsome, Depression, Dextromethorphan, Bupropion, Sigma-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 30 May 2018 (actual)
Primary completion: 7 Jan 2019 (actual)
Study completion: 7 Jan 2019 (actual)
First posted: 23 Jul 2018 (actual)
Results: Posted 24 Sep 2021

Clinical summary

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

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AXS-05	Experimental	Drug: AXS-05
Bupropion	Active comparator	Drug: Bupropion

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Currently meets DSM-5 criteria for MDD
Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

Key exclusion criteria (5 listed)

Suicide risk
History of treatment resistance in current depressive episode
History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Additional criteria may apply

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
AXS-05AXS-05 taken twice daily for 6 weeks.	Drug	AXS-05
BupropionBupropion taken twice daily for 6 weeks.	Drug	Bupropion

Primary outcome

MADRS Score - Overall Change From Baseline
Time frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)
The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

Results and safety

Results posted to the registry on 24 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AXS-05	48	38
Bupropion	49	35

Primary outcome: MADRS Score - Overall Change From Baseline

Time frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period). Mean (Standard Error). Unit: score on a scale

Measure	AXS-05 n = 43	Bupropion n = 37
Value	13.7 (0.63)	8.8 (0.68)

AXS-05 vs Bupropion: p <.001, Mixed Models Analysis

Population analysed: modified Intent-to-Treat (mITT) Population

Adverse events

Time frame: Adverse events were collected from the time of signing the ICF through 30 days after the last study visit or Early Termination (ET), whichever occurred first, an average of 11 weeks per participant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AXS-05	0 of 48 (0%)	35 of 48 (72.9%)	0 of 48
Bupropion	0 of 48 (0%)	30 of 48 (62.5%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35582785Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. via publication

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AXS-05 and Bupropion in people with Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 4 sites 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 4 inclusion and 5 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 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 Sep 2021). 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?

MADRS Score - Overall Change From Baseline (time frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)). 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 NCT03595579, which also lists 1 linked publication.

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 24 Sep 2021.