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Drug: CVL-354 for Depression

Phase 1
Waitlist Available
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 29 days following last dose with imp
Awards & highlights

Study Summary

This trial is testing a new drug, CVL-354, to see if it is safe and effective. The trial has two parts. In the first part, participants will receive either the drug or a placebo, and in the second part participants will receive multiple doses of the drug. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the drug or the placebo.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 days following last dose with imp
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days following last dose with imp for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Part A&B: Changes in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Primary Part A&B: Incidence and severity of Treatment -Emergent Adverse Events (TEAEs)
Primary Part A&B: Incidence of clinically significant changes in clinical laboratory results
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Ascending Dose (SAD) Cohorts 1-3Experimental Treatment2 Interventions
In Cohorts 1 and 2, all participants will receive treatment with up to 3 single oral doses of CVL-354 and/or 1 single oral dose of placebo in a 4-period crossover design. The starting dose of CVL-354 will be 0.5 mg. Participants will be randomized to 1 of 4 treatment sequences. Cohort 3 may be used to evaluate additional doses or evaluate food effect, depending on the results from Cohorts 1 and 2.
Group II: Multiple Ascending Dose (MAD) Cohorts 1-5Experimental Treatment2 Interventions
All participants will receive treatment with multiple oral doses of CVL-354 (dose and regimen to be determined) or matching placebo for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Drug: CVL-354
2021
Completed Phase 1
~80
Drug: Placebo
2013
Completed Phase 3
~660

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,642 Total Patients Enrolled
Matthew Leoni, MD, MBAStudy DirectorCerevel Therapeutics, LLC
2 Previous Clinical Trials
31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for enrollment in this investigation higher than 25 years?

"This clinical trial welcomes individuals aged 18 and above but not exceeding 55 years old."

Answered by AI

Has the FDA authorized Drug: CVL-354?

"With only limited data on its efficacy and safety, Drug: CVL-354 received a score of 1 in our assessment."

Answered by AI

Does this trial have any remaining openings for participants?

"Affirmative. According to clinicaltrials.gov, this study is still open for enrollment; the initial posting was on October 18th 2021 and it was last updated November 17th 2021. The research team needs 74 individuals from a single site to complete their investigation."

Answered by AI

What is the total number of participants who are partaking in this research?

"Affirmative! According to clinicaltrials.gov, this study is actively seeking participants after being first posted on October 18th 2021 and last updated on November 17th 2021. 74 volunteers are sought-after at one medical facility."

Answered by AI

Is this clinical trial open to any and all individuals?

"This trial seeks 74 individuals suffering from depression who are between 18 and 55 years old. These applicants should have a BMI of 18.5 to 30 kg/m2, weigh at least 50 kilograms (110 pounds), be able to comprehend the particulars of this study and comply with its protocols, and women must not be childbearing capable while men need to fall within these age parameters."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Labcorp Drug Development
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
2021. "A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05138653.
~21 spots leftby Apr 2025
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