Major Depressive Disorder
Conditions
Keywords
depression, depressed, depressive disorder, major depression, major depressive episode, antidepressant
Brief summary
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
Interventions
DRUGBHV-7000
BHV-7000 75 mg taken once daily for 6 weeks
DRUGPlacebo
Matching placebo taken once daily for 6 weeks
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6 | 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. |
| Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1 | 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). |
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1 | 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. |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score | 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). |
| Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score | 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. |
| Number of Participants With Clinically Significant Laboratory Abnormalities | 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. |
| Number of Participants With Vital Sign Abnormalities | Screening through Week 8 | — |
| Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation | Screening through Week 8 | — |
| Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication | 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 |
Countries
United States
Outcome results
None listed