ACP-211 Monoterapi för Större Depressivt Syndrom med Otillräckligt Antidepressivt Svar (NORLIGHT)
En dubbelblind, placebokontrollerad, parallellgruppsstudie för att utvärdera effekt och säkerhet av ACP-211-monoterapi hos vuxna med större depressiv störning och otillräckligt svar på antidepressiv behandling
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).
The main questions the study aims to answer are:
- Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?
- What adverse events do participants have when taking ACP-211?
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Sandy Filosi
- Telefonnummer: +1(609) 250-6920
- E-post: sfilosi@ACADIA-Pharm.com
Studera Kontakt Backup
- Namn: Lori Lykens
- Telefonnummer: +1(609) 250-6917
- E-post: lori.lykens@acadia-pharm.com
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- Indragen
- University of Alabama at Birmingham
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California
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Chino, California, Förenta staterna, 91710
- Rekrytering
- Inland Psychiatric Medical Group
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Glendale, California, Förenta staterna, 91107
- Rekrytering
- Behavioral Research Specialists, LLC
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La Jolla, California, Förenta staterna, 92037
- Rekrytering
- Kadima Neuropsychiatry Institute
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Orange, California, Förenta staterna, 92866
- Rekrytering
- PNS Clinical Research LLC dba ATP Clinical Research
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West Hills, California, Förenta staterna, 91307
- Rekrytering
- Focus Clinical Research, LLC d/b/a Alliance Clinical West Hills
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Colorado
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Denver, Colorado, Förenta staterna, 80209
- Rekrytering
- Mountain View Clinical Research
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Florida
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Fort Myers, Florida, Förenta staterna, 33901
- Rekrytering
- New Access Research and Medical Services, Inc.
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Hollywood, Florida, Förenta staterna, 33021
- Rekrytering
- The Medici Medical Research
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Largo, Florida, Förenta staterna, 33777
- Indragen
- Sandhill Research, LLC/DBA Accel Research Sites
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Orlando, Florida, Förenta staterna, 32801
- Rekrytering
- Clinical Neuroscience Solutions, Inc.
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Tampa, Florida, Förenta staterna, 33629
- Rekrytering
- IPTB Clinical Research
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West Palm Beach, Florida, Förenta staterna, 33407
- Rekrytering
- Neuroscience Research Institute, Inc.
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Massachusetts
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Watertown, Massachusetts, Förenta staterna, 02472
- Rekrytering
- Adams Clinical, Inc.
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Worcester, Massachusetts, Förenta staterna, 01608
- Rekrytering
- Vitalix Clinical, Inc.
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Mississippi
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Flowood, Mississippi, Förenta staterna, 39232
- Rekrytering
- Precise Research Centers
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Missouri
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Saint Charles, Missouri, Förenta staterna, 63304
- Rekrytering
- St. Charles Psychiatric Associates, Inc. dba Midwest Research Group
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68526
- Rekrytering
- Alivation Research, LLC
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89134
- Rekrytering
- Redbird Research LLC
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New Jersey
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Marlton, New Jersey, Förenta staterna, 08053
- Indragen
- CenExel Hassman Research Institute, LLC
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New York
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Brooklyn, New York, Förenta staterna, 11229
- Rekrytering
- Integrative Clinical Trials LLC
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North Carolina
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Cary, North Carolina, Förenta staterna, 27511
- Rekrytering
- Magnolia Clinical Research, LLC
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Ohio
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North Canton, Ohio, Förenta staterna, 44720
- Rekrytering
- Neuro-Behavioral Clinical Research
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Texas
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Baylor College of Medicine
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Houston, Texas, Förenta staterna, 77081
- Indragen
- Dynamed Clinical Research LP d/b/a DM Clinical Research
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Katy, Texas, Förenta staterna, 77450
- Rekrytering
- Olympus Clinical Research, LLC
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The Woodlands, Texas, Förenta staterna, 77381
- Rekrytering
- Family Psychiatry of The Woodlands
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Utah
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Salt Lake City, Utah, Förenta staterna, 84105
- Rekrytering
- Aura Wellness
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults ≥18 and ≤65 years of age
- Provides written informed consent
- Clinical diagnosis of MDD
- History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode
- Currently treated with an approved antidepressant at a stable dose prior to Screening
- MADRS total score ≥28, CGI-S score ≥4, and QIDS-SR16 score ≥14 at Screening and Baseline
- Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation
Exclusion Criteria:
- Current diagnosis of certain personality disorders or persistent depressive disorder
- Recent substance use disorders, excluding caffeine or nicotine
- Active suicidal risk or recent suicidal attempt
- History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features
- Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD
- History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)
- Allergy or sensitivity to ketamine or esketamine
- Significant cardiovascular disease
- Positive history of hepatitis B, hepatitis C, or HIV infection
- Unstable diabetes or uncontrolled medical conditions
- Positive urine drug test for an illicit drug or cannabis
- Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode
- Recent initiation or change in psychotherapy
Additional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ACP-211 600 mg
ACP-211 600 mg, administered orally twice weekly |
ACP-211 monotherapy |
|
Experimentell: ACP-211 300 mg
ACP-211 300 mg, administered orally twice weekly |
ACP-211 monotherapy |
|
Placebo-jämförare: Placebo
Matching placebo, administered orally twice weekly |
Placebo control |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
Tidsram: Baseline and Day 28
|
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity. |
Baseline and Day 28
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits
Tidsram: Baseline through Day 28
|
Baseline through Day 28
|
|
|
Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10)
Tidsram: Up to Day 28
|
Up to Day 28
|
|
|
Proportion of Subjects With Response at Scheduled Postbaseline Visits (≥50% Reduction From Baseline in MADRS Total Score)
Tidsram: Up to Day 28
|
Up to Day 28
|
|
|
Change From Baseline in MADRS Total Score at Day 2
Tidsram: Baseline and Day 2 (24 hours postdose)
|
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity. |
Baseline and Day 2 (24 hours postdose)
|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits
Tidsram: Baseline through Day 28
|
The CGI-S is a clinician-rated assessment of illness severity scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater illness severity. |
Baseline through Day 28
|
|
Proportion of Subjects With Sustained Response From Day 2 Through Day 28
Tidsram: Day 2 through Day 28
|
Subjects achieving sustained response, defined as a ≥50% reduction from Baseline in MADRS total score, with onset by Day 2 and maintained through the end of the double-blind treatment period. |
Day 2 through Day 28
|
|
Proportion of Subjects With Clinical Global Impression of Improvement (CGI-I) Score of 1 or 2 at Scheduled Postbaseline Visits
Tidsram: Up to Day 28
|
The CGI-I is a clinician-rated assessment of change in illness relative to Baseline. Scores range from 1 (very much improved) to 7 (very much worse). This outcome evaluates subjects with a score of 1 (very much improved) or 2 (much improved). |
Up to Day 28
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ACP-211-002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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