Adjunctive Treatment of Major Depressive Disorder
Conditions
Brief summary
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.
Interventions
DRUGPimavanserin
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059 2. May benefit from longer term therapy with open-label pimavanserin treatment 3. If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception
Exclusion criteria
1. Is determined to be inappropriate for the study 2. Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program Additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs) | 52 weeks | Number of patients with treatment emergent AEs |
Countries
Finland, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The study recruited patients that had completed a previous study of pimavanserin, i.e. either study ACP-103-054 or ACP-103-059. It was planned to enroll about 420 patients in total. The study was terminated early by the Sponsor for business reasons due to the COVID-19 pandemic; there were no safety concerns contributing to study termination (see Caveats and Limitations). A total of 235 patients were enrolled and treated instead of the anticipated number of about 420 patients.
Pre-assignment details
During the screening period, subjects were assessed for study eligibility and prohibited medications were discontinued when medically appropriate.
Participants by arm
| Arm | Count |
|---|---|
| Pimavanserin Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks | 235 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Noncompliance with study drug | 4 |
| Overall Study | Not further specified | 8 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Study terminated by sponsor | 98 |
| Overall Study | Use of prohibited medication | 3 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | Pimavanserin |
|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 13.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 219 Participants |
| Region of Enrollment Finland | 10 participants |
| Region of Enrollment Poland | 16 participants |
| Region of Enrollment Russia | 26 participants |
| Region of Enrollment Serbia | 13 participants |
| Region of Enrollment Slovakia | 5 participants |
| Region of Enrollment South Africa | 1 participants |
| Region of Enrollment Ukraine | 26 participants |
| Region of Enrollment United Kingdom | 27 participants |
| Region of Enrollment United States | 111 participants |
| Sex: Female, Male Female | 165 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 235 |
| other Total, other adverse events | 69 / 235 |
| serious Total, serious adverse events | 5 / 235 |
Outcome results
Primary
Treatment-emergent Adverse Events (TEAEs)
Number of patients with treatment emergent AEs
Time frame: 52 weeks
Population: All patients enrolled who received at least one dose of study medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pimavanserin | Treatment-emergent Adverse Events (TEAEs) | 137 Participants |