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
Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled. This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
298
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Placebo (2×placebo tablets \[size- and color-matched to pimavanserin\]) administered orally as a single dose once daily
Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
Time frame: Baseline, Week 5
Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms
The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression.
Time frame: Baseline, 5 weeks
Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score
The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability.
Time frame: Baseline, 5 weeks
Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form
The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning.
Time frame: Baseline, 5 weeks
Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score
The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
CNS Network
Garden Grove, California, United States
Behavioral Research Specialists
Glendale, California, United States
Sun Valley Research Center
Imperial, California, United States
Irvine Clinical Research
Irvine, California, United States
Synergy San Diego
Lemon Grove, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
NRC Research Institute
Orange, California, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
...and 75 more locations
Time frame: Baseline, 5 weeks
Change From Baseline to Week 1 in the HAMD-17 Total Score
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
Time frame: Baseline, 1 week
Treatment Responder and Treatment Remission Rates at Week 5
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7.
Time frame: Baseline, 5 weeks
Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score
The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition.
Time frame: Baseline, 5 weeks
Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)
The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness.
Time frame: Baseline, 5 weeks
Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5
The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression.
Time frame: Baseline, 5 weeks