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Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Phase 3 trial testing Pimavanserin in Adjunctive Treatment of Major Depressive Disorder in 298 participants. Completed in 29 May 2020.
| Lead sponsor | ACADIA Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 298 |
| Start date | 25 April 2019 |
| Primary completion | 30 April 2020 |
| Estimated completion | 29 May 2020 |
| Sites | 85 locations across South Africa, Finland, Russia, Slovakia, Ukraine, Serbia, United Kingdom, Poland |
ACADIA Pharmaceuticals Inc. — full company profile →
18 and older, any sex, with Adjunctive Treatment of Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -9.0 | ± 0.58 |
| Placebo | -8.1 | ± 0.58 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -1.4 | ± 0.10 |
| Placebo | -1.1 | ± 0.10 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -2.5 | ± 0.22 |
| Placebo | -2.1 | ± 0.22 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | 3.4 | ± 0.66 |
| Placebo | 2.5 | ± 0.66 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -1.4 | ± 0.15 |
| Placebo | -0.8 | ± 0.15 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -3.8 | ± 0.34 |
| Placebo | -3.2 | ± 0.34 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | 46 | |
| Placebo | 46 |
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | 27 | |
| Placebo | 25 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -2.5 | ± 0.21 |
| Placebo | -2.5 | ± 0.21 |
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
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | -3.0 | ± 0.64 |
| Placebo | -2.5 | ± 0.64 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | 2.7 | ± 0.09 |
| Placebo | 2.9 | ± 0.09 |
Time frame: Adverse Events (AEs) were to be documented through 30 days after the last planned dose in the study which was to be administered at Week 6.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pimavanserin | Placebo |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Multiple sclerosis | Nervous system disorders | — | — |
| Gastritis haemorrhagic | Gastrointestinal disorders | — | — |
| Reaction | System | Pimavanserin | Placebo |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
Most-reported serious reactions: Atrial fibrillation, Lower gastrointestinal haemorrhage, Multiple sclerosis, Gastritis haemorrhagic.
Data from ClinicalTrials.gov NCT03968159 adverse events section.
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
5 peer-reviewed publications reference this trial (live from Europe PMC):
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