Phase 2
N=207
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
Adjunctive Treatment of Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03018340 ↗Enrolled (actual)
207
Serious AEs
0.8%
Results posted
Nov 2019
Primary outcome: Primary: Change From Baseline to Week 5 in the HAMD-17 Total Score — 22.9; 22.0; 20.3; 20.4 score on a scale — p=0.0390
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pimavanserin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 5 in the HAMD-17 Total Score |
22.9; 22.0; 20.3; 20.4; -11.9; -7.1 | 0.0390 sig |
| SECONDARY Change From Baseline to Week 5 in the SDS Total Score |
6.365; 6.519; 5.753; 5.747; -3.229; -2.026 | — |
| SECONDARY Treatment Response and Remission Rates at the End of 5-week Treatment Period |
27; 38; 2; 2; 12; 17 | — |
| SECONDARY Change From Baseline to Week 5 in CGI-S Total Score |
4.6; 4.4; 4.1; 4.1; -2.0; -1.1 | — |
| SECONDARY CGI-I Score at Week 5 |
2.2; 2.8; 3.0; 3.1 | — |
| SECONDARY Change From Baseline to Week 5 in SF-12 Score |
49.587; 48.783; 46.945; 48.994; -0.981; -0.726 | — |
| SECONDARY Change From Baseline to Week 5 in DAI-10 Score |
4.2; 4.4; 5.1; 4.8; 1.4; 0.5 | — |
| SECONDARY Change From Baseline to Week 5 in KSS Score |
6.7; 6.6; 6.7; 6.1; -1.9; -0.4 | — |
| SECONDARY Change From Baseline to Week 5 in MGH-SFI Score |
4.642; 4.457; 4.678; 4.264; -0.830; -0.155 | — |
| SECONDARY Change From Baseline to Week 5 in BIS-11 Score |
72.5; 70.0; 65.9; 70.3; -4.2; -2.8 | — |
| SECONDARY Change From Baseline to Week 5 in SIS Score |
38.9; 38.8; 35.2; 36.6; -19.4; -10.8 | — |
Summary
To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and 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 as monotherapy:
- Citalopram
- Escitalopram
- Paroxetine
- Fluoxetine
- Sertraline
- Duloxetine
- Venlafaxine
- Desvenlafaxine
- Venlafaxine XR
- Has a history of inadequate response to antidepressant treatments
Exclusion Criteria
- Patient has a psychotic disorder other than MDD
- Patient has current evidence of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
- Patient has a history or symptoms of long QT syndrome
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 (NCT03018340). 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.