Phase 3
N=298
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Adjunctive Treatment of Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03968159 ↗Enrolled (actual)
298
Serious AEs
1.3%
Results posted
Nov 2021
Primary outcome: Primary: Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score — -9.0; -8.1 score on a scale — p=0.2956
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pimavanserin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score |
-9.0; -8.1 | 0.2956 |
| SECONDARY Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms |
-1.4; -1.1 | — |
| SECONDARY Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score |
-2.5; -2.1 | — |
| SECONDARY Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form |
3.4; 2.5 | — |
| SECONDARY Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score |
-1.4; -0.8 | — |
| SECONDARY Change From Baseline to Week 1 in the HAMD-17 Total Score |
-3.8; -3.2 | — |
| SECONDARY Treatment Responder and Treatment Remission Rates at Week 5 |
46; 46; 27; 25 | — |
| SECONDARY Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score |
-2.5; -2.5 | — |
| SECONDARY Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11) |
-3.0; -2.5 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5 |
2.7; 2.9 | — |
Summary
To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
Eligibility Criteria
Inclusion Criteria
- Adult patients, aged 18 years and above
- A clinical diagnosis of major depressive disorder (MDD)
- Is being treated with one of the following SSRI or SNRI antidepressants:
- Citalopram
- Escitalopram
- Paroxetine
- Fluoxetine
- Sertraline
- Duloxetine
- Venlafaxine
- Desvenlafaxine
- Venlafaxine XR
- Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception
Exclusion Criteria
- Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
- Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
- Has a known history or symptoms of long QT syndrome
- Is determined to be inappropriate for the study for any reason
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Data sourced from ClinicalTrials.gov (NCT03968159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.