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Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder

ConditionMajor Depressive Disorder (MDD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSupernus Pharmaceuticals, Inc.

About this trial

This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI

Duration of current MDE of at least 8 weeks

MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit

CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit

Disqualifiers

MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit

History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE

History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit

Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPN-821 2400 mg

    Drug

    SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling

  • Placebo

    Drug

    Matched placebo oral tablets

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: SPN-821 2400 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.

MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.

Time frame
4 weeks

Secondary outcomes

1

Change From Baseline to Day 29 in the Clinical Global Impression - Severity of Illness Score (CGI-S).

CGI-S is a single-item clinician rating of the clinician's assessment of the severity of symptoms in relation to the clinician's total experience with patients with that condition. The CGI-I is rated on a 7-point scale from 1 to 7, where 1 = "normal not at all ill" and 7 = "among the most extremely ill patients". Successful therapy is indicated by a lower overall score.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Supernus Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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