ACP-211 Monoterapi for alvorlig depresjonslidelse med utilstrekkelig antidepressiv respons (NORLIGHT)
En dobbeltblind, placebokontrollert, parallellgruppe-studie for effekt og sikkerhet av ACP-211 monoterapi hos voksne med major depresjonslidelse og utilstrekkelig respons 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?
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Sandy Filosi
- Telefonnummer: +1(609) 250-6920
- E-post: sfilosi@ACADIA-Pharm.com
Studer Kontakt Backup
- Navn: Lori Lykens
- Telefonnummer: +1(609) 250-6917
- E-post: lori.lykens@acadia-pharm.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Tilbaketrukket
- University of Alabama at Birmingham
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California
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Chino, California, Forente stater, 91710
- Rekruttering
- Inland Psychiatric Medical Group
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Glendale, California, Forente stater, 91107
- Rekruttering
- Behavioral Research Specialists, LLC
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La Jolla, California, Forente stater, 92037
- Rekruttering
- Kadima Neuropsychiatry Institute
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Orange, California, Forente stater, 92866
- Rekruttering
- PNS Clinical Research LLC dba ATP Clinical Research
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West Hills, California, Forente stater, 91307
- Rekruttering
- Focus Clinical Research, LLC d/b/a Alliance Clinical West Hills
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Colorado
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Denver, Colorado, Forente stater, 80209
- Rekruttering
- Mountain View Clinical Research
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Rekruttering
- New Access Research and Medical Services, Inc.
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Hollywood, Florida, Forente stater, 33021
- Rekruttering
- The Medici Medical Research
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Largo, Florida, Forente stater, 33777
- Tilbaketrukket
- Sandhill Research, LLC/DBA Accel Research Sites
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Orlando, Florida, Forente stater, 32801
- Rekruttering
- Clinical Neuroscience Solutions, Inc.
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Tampa, Florida, Forente stater, 33629
- Rekruttering
- IPTB Clinical Research
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West Palm Beach, Florida, Forente stater, 33407
- Rekruttering
- Neuroscience Research Institute, Inc.
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Massachusetts
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Watertown, Massachusetts, Forente stater, 02472
- Rekruttering
- Adams Clinical, Inc.
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Worcester, Massachusetts, Forente stater, 01608
- Rekruttering
- Vitalix Clinical, Inc.
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Mississippi
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Flowood, Mississippi, Forente stater, 39232
- Rekruttering
- Precise Research Centers
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Missouri
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Saint Charles, Missouri, Forente stater, 63304
- Rekruttering
- St. Charles Psychiatric Associates, Inc. dba Midwest Research Group
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Nebraska
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Lincoln, Nebraska, Forente stater, 68526
- Rekruttering
- Alivation Research, LLC
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Nevada
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Las Vegas, Nevada, Forente stater, 89134
- Rekruttering
- Redbird Research LLC
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New Jersey
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Marlton, New Jersey, Forente stater, 08053
- Tilbaketrukket
- CenExel Hassman Research Institute, LLC
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New York
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Brooklyn, New York, Forente stater, 11229
- Rekruttering
- Integrative Clinical Trials LLC
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North Carolina
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Cary, North Carolina, Forente stater, 27511
- Rekruttering
- Magnolia Clinical Research, LLC
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Ohio
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North Canton, Ohio, Forente stater, 44720
- Rekruttering
- Neuro-Behavioral Clinical Research
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Baylor College of Medicine
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Houston, Texas, Forente stater, 77081
- Tilbaketrukket
- Dynamed Clinical Research LP d/b/a DM Clinical Research
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Katy, Texas, Forente stater, 77450
- Rekruttering
- Olympus Clinical Research, LLC
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The Woodlands, Texas, Forente stater, 77381
- Rekruttering
- Family Psychiatry of The Woodlands
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Utah
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Salt Lake City, Utah, Forente stater, 84105
- Rekruttering
- Aura Wellness
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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 ≥16 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ACP-211 600 mg
ACP-211 600 mg, administered orally twice weekly |
ACP-211 monotherapy |
|
Eksperimentell: ACP-211 300 mg
ACP-211 300 mg, administered orally twice weekly |
ACP-211 monotherapy |
|
Placebo komparator: Placebo
Matching placebo, administered orally twice weekly |
Placebo control |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits
Tidsramme: Baseline through Day 28
|
Baseline through Day 28
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|
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Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10)
Tidsramme: 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)
Tidsramme: Up to Day 28
|
Up to Day 28
|
|
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Change From Baseline in MADRS Total Score at Day 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACP-211-002
Plan for individuelle deltakerdata (IPD)
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