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Completed

NCT Number: NCT06419608

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

The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Consciousness Disorders Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IMA Clinical Research, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Subjects experiencing a moderate to severe episode of depression.
  • Subjects experiencing a current episode of depression for at least 2 months.
  • Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
  • Male and Female participants 18 to 75 years of age at the time of consent.
  • Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.

Key Exclusion Criteria:

  • Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
  • Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
  • Subjects with a history of medical conditions that may interfere with the conduct of the study.
  • Females who are pregnant, breastfeeding or planning to become pregnant.

Treatment and study plan

BHV-7000

Drug

BHV-7000 75 mg taken once daily for 6 weeks

Placebo

Drug

Matching placebo taken once daily for 6 weeks

Primary outcomes

  1. Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6

    Time frame: Baseline to Week 6

    The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).

Secondary outcomes

  1. Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score

    Time frame: Baseline to Week 6

    The CGI-S is a clinician-rated scale to assess disease severity. The scale is scored on 8-point scale (0 [not assessed] to 7 [severe]). A higher score represents a higher severity illness.

  2. Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6

    Time frame: Baseline to Week 6

    The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.

  3. Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1

    Time frame: Baseline to Week 1

    The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).

  4. Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1

    Time frame: Baseline to Week 1

    The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.

  5. Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score

    Time frame: Baseline to Week 6

    The Q-LES-Q-SF is a participant self-administered scale to assess the degree of enjoyment and satisfaction experienced in various areas of daily functioning. The form consists of 16 items. Each item is scored on 5-point scale. A higher score represents a higher level of satisfaction and enjoyment (total scores range from 14 to 70).

  6. Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication

    Time frame: Screening through Week 8

    Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication

  7. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Screening through Week 8

    To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.

  8. Number of Participants With Vital Sign Abnormalities

    Time frame: Screening through Week 8

  9. Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation

    Time frame: Screening through Week 8

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 17, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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