Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression

Launched by BIOHAVEN THERAPEUTICS LTD. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BHV-7000 for people with Major Depressive Disorder (MDD). The goal is to see how well this treatment works and how safe it is for individuals experiencing moderate to severe depression. The study is currently looking for participants aged 18 to 75 who have been feeling depressed for at least two months and are willing to stop taking other medications for depression before joining the trial.

If you or someone you know is struggling with depression and meets the eligibility criteria, this trial could be an option. Participants will receive the treatment and will be closely monitored by the research team throughout the study. It's important to note that individuals with certain medical histories or currently taking multiple depression medications may not qualify. Overall, this trial aims to explore a new option for those who need help managing their depression.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Subjects experiencing a moderate to severe episode of depression.
• • 2. Subjects experiencing a current episode of depression for at least 2 months.
• • 3. Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
• • 4. Male and Female participants 18 to 75 years of age at the time of consent.
• • 5. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
• Key Exclusion Criteria:
• • 1. Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
• • 2. Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
• • 3. Subjects with a history of medical conditions that may interfere with the conduct of the study.
• • 4. Females who are pregnant, breastfeeding or planning to become pregnant.