ACP-211 for Depression
(NORLIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new drug, ACP-211, can benefit individuals with major depressive disorder (MDD) who haven't improved with standard antidepressant medications. Researchers seek to compare the effectiveness of ACP-211 against a placebo (a pill with no medicine) in reducing depression symptoms and to identify any side effects. The trial will evaluate two different doses of ACP-211. Individuals who have tried at least two different antidepressants without success and still experience significant depression may be suitable candidates for this study. As a Phase 2 trial, this study focuses on assessing the effectiveness of ACP-211 in an initial, smaller group of participants.
Will I have to stop taking my current medications?
You may need to stop taking your current antidepressant and augmentation medications at least 5 half-lives before the study starts, and you cannot take them within 14 days before the study begins. Other medications like benzodiazepines and certain sleep aids are also restricted around the time of taking the study drug.
Is there any evidence suggesting that ACP-211 is likely to be safe for humans?
Research is exploring ACP-211 as a potential treatment for major depressive disorder. Although detailed safety information from human studies remains limited, some insights are available. ACP-211 is related to R-Norketamine, a compound similar to ketamine, which is already used to treat depression. Researchers are investigating whether ACP-211 might be effective with fewer side effects.
Since ACP-211 is in early testing stages, most safety information comes from pre-human studies. These studies suggest that ACP-211 could be promising, but more human data is needed to understand its tolerability and potential side effects.
ACP-211 is currently in a Phase 2 trial, indicating it has passed initial safety tests in smaller groups. This demonstrates a basic level of safety, but researchers are closely monitoring for adverse side effects as more participants try the treatment. Participants in this trial will provide crucial information on the safety of ACP-211 for treating depression.12345Why do researchers think this study treatment might be promising for depression?
Researchers are excited about ACP-211 because it represents a new approach to treating depression. Unlike traditional antidepressants, which often target serotonin, ACP-211 is being investigated for its ability to interact with different brain pathways, potentially offering relief for patients who do not respond well to existing medications like SSRIs or SNRIs. The treatment's unique dosing schedule, with oral administration just twice a week, could also enhance convenience and adherence compared to daily pill regimens. This novel mechanism and delivery method could make a significant difference in the lives of those struggling with depression.
What evidence suggests that ACP-211 might be an effective treatment for depression?
Research shows that ACP-211 is being tested as a potential treatment for major depressive disorder (MDD), particularly for individuals unresponsive to regular antidepressants. Early results suggest that ACP-211 might alleviate depression symptoms by affecting specific brain pathways that regulate mood. In this trial, participants will receive either 600 mg of ACP-211, 300 mg of ACP-211, or a placebo, administered orally twice weekly. Ongoing studies aim to confirm whether ACP-211 can significantly improve depression symptoms compared to a placebo. Monitoring new data will reveal how effectively ACP-211 might work for those with treatment-resistant depression.13678
Are You a Good Fit for This Trial?
Adults with major depressive disorder (MDD) who haven't gotten better after trying other antidepressants can join this trial. Specific details about what makes someone eligible or not are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ACP-211 or placebo orally twice weekly
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ACP-211
Trial Overview
The study is testing if ACP-211 is more effective than a placebo in reducing depression symptoms in adults with MDD, particularly those whose condition didn't improve with standard treatments.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
ACP-211 600 mg, administered orally twice weekly
ACP-211 300 mg, administered orally twice weekly
Matching placebo, administered orally twice weekly
Find a Clinic Near You
Who Is Running the Clinical Trial?
ACADIA Pharmaceuticals Inc.
Lead Sponsor
Citations
ACP-211 Monotherapy for Major Depressive Disorder With ...
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 ...
2.
acadia.com
acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-hosts-inaugural-rd-day-showcasingAcadia Pharmaceuticals Hosts Inaugural R&D Day ...
Q4 2025 - Phase 2 study initiation for ACP-211 in major depressive disorder (MDD); Q4 2025 - First in human study of ACP-271 in healthy ...
3.
biopharmadive.com
biopharmadive.com/news/acadia-ceo-owens-adams-neuroscience-pipeline-sales-forecasts/752137/Acadia CEO sets sights on 'much more assertive' deals to ...
Forecasting Acadia's pipeline potential ; ACP-211, Ph. 2, Major depressive disorder, >$2B ; ACP-271, Ph. 1-ready, Huntington's disease, tardive ...
ACP-211 - Drug Targets, Indications, Patents
100 Clinical Results associated with ACP-211. Login to view more data. 100 Translational Medicine associated with ACP-211. Login to view more data.
A Living Clinical Guideline From the American College of ...
ACP recommends monotherapy with either cognitive behavioral therapy or a second-generation antidepressant as initial treatment in patients in the acute phase.
Annual Report - Investors - Acadia Pharmaceuticals Inc.
In November 2023, we initiated the Phase 3 COMPASS PWS study evaluating the efficacy and safety of ACP-101 for the treatment of hyperphagia in ...
7.
trial.medpath.com
trial.medpath.com/news/32bbc493a6694b76/acadia-pharmaceuticals-unveils-12-billion-pipeline-strategy-at-inaugural-r-d-dayAcadia Pharmaceuticals $12B Pipeline Strategy at R&D Day
ACP-211 is described as an orally administered, selectively deuterated form of R-NorketamineSearch drug for the potential treatment of major depressive disorder ...
8.
investing.com
investing.com/news/transcripts/acadia-pharmaceuticals-at-td-cowen-summit-strategic-pipeline-insights-93CH-4245893Acadia Pharmaceuticals at TD Cowen Summit
I do want to be clear, ACP-211 is currently early stage, and our understanding of that safety profile is informed by preclinical experiments and ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.