Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
508 (estimated)
Sponsor
Axsome Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with major depressive disorder and excessive daytime sleepiness symptoms. Participants will first take solriamfetol openly, followed by a period where neither the participant nor the doctor knows if the treatment is the drug or a placebo.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with major depressive disorder.
I have excessive daytime sleepiness symptoms.
I am able to follow the study procedures.
I am a male or female between 18 and 65 years old.
You may not be able to join if
I have a significant medical disorder, like narcolepsy or sleep apnea.
I am unable to follow the study procedures.
I am not considered suitable for this study by the investigator.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment…
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
* Excessive daytime sleepiness symptoms
* Able to comply with study procedures
* Male or female, aged 18 to 65 years inclusive
Exclusion Criteria:
* Any clinically significant medic…
Inclusion Criteria:
* Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
* Excessive daytime sleepiness symptoms
* Able to comply with study procedures
* Male or female, aged 18 to 65 years inclusive
Exclusion Criteria:
* Any clinically significant medical (e.g., OSA, narcolepsy), behavioral, or psychiatric disorder, other than MDD with EDS symptoms
* Unable to comply with study procedures
* Medically inappropriate for study participation in the opinion of the investigator
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