Major Depressive Disorder MedDRA version: 21.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873
Conditions
Sponsors
ACADIA Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 in the judgment of the Investigator 3.Is willing and able to provide informed consent. Consent for the present study must be obtained prior to the procedures being performed at the Week 6/EOT visit of Study ACP 103 054 or Study ACP-103-059 4.Is capable of communicating with the site personnel, able to complete subject-reported outcome measures and can be reliably rated on assessment scales (in the opinion of the Investigator) 5.If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) OR must agree to use TWO clinically acceptable methods of contraception during the study and 1 month following completion of the study. Acceptable methods of contraception include the following: a.A barrier method,condom, diaphragm, or cervical cap with spermicide b.Hormonal contraception, including oral, injectable, transdermal, or implantable methods c.Intrauterine device (IUD) Only one of the two clinically acceptable methods can be a hormonal method. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1.Is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to adverse events, medical condition, or noncompliance with investigational product or study procedures in Study ACP-103-054 or Study ACP-103-059, or is judged to be a danger to self or others 2.Has any of the following electrocardiogram (ECG) results at Baseline (i.e.: Week 6/EOT visit of Study ACP-103-054 or Study ACP-103-059): a.If the subject is not on citalopram, escitalopram, or venlafaxine (immediate or extended release): i.QTcF >450 ms, if QRS duration 470 ms, if QRS duration =120 ms b.If the subject is on citalopram, escitalopram, or venlafaxine (immediate or extended release): i.QTcF >425 ms, if QRS duration 450 ms, if QRS duration =120 ms 3.Has a heart rate (as measured by peripheral pulse rate) <50 beats per minute at Baseline (i.e., the Week 6/EOT visit of Study ACP 103 054 or Study ACP-103-059) not explained by regular exercise or medication, in discussion with the Medical Monitor 4.Has a body mass index (BMI) <18.5 kg/m2 or known unintentional clinically significant weight change (i.e., +/- =7% of body weight) in Study ACP 103 054 or Study ACP-103-059 as assessed by the Investigator 5.Has clinically significant laboratory abnormalities that, in the judgment of the Investigator or Medical Monitor, would either: a.jeopardize the safe participation of the subject in the study; OR b.would interfere with the conduct or interpretation of safety or efficacy evaluations in the study 6.Is suicidal as defined below at Visit 1 (Baseline) of the present study: a.An answer of “yes” to C SSRS questions 4 or 5 (current or over the last 6 months); OR b.Has attempted suicide within 1 year prior to Visit 1 (Baseline); OR c.Is actively suicidal in the Investigator’s judgment 7.Has developed delirium or a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator or the Medical Monitor, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study 8.Requires treatment with a medication or other substance that is prohibited by the protocol 9.Has a significant sensitivity or allergic reaction to pimavanserin or its excipients 10.Is an employee or is a family member of an employee of ACADIA Pharmaceuticals Inc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment;Secondary Objective: Exploratory Objectives •To explore the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment on the following: - suicidality - extrapyramidal symptoms - general health assessments •To explore the benefits of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment on the following: improvement of depression symptoms clinical global impression of severity of depressive symptoms general health assessments •To explore the benefits of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment on the following: improvement of depression symptoms clinical global impression of severity of depressive symptoms functional impairment sexual functioning ;Primary end point(s): Treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: After final Database lock | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory Endpoints Safety and tolerability endpoints: •Columbia–Suicide Severity Rating Scale (C-SSRS) •Extrapyramidal Symptom Rating Scale–Abbreviated (ESRS-A) score •Vital signs •Body weight •Potentially clinically important laboratory values Efficacy endpoints: •Change from Baseline in Hamilton Depression Scale (17 items) (HAMD-17) total score •Treatment responder rates. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. •Treatment remission rates. Treatmentremission is defined as a HAMD-17 total score =7. •Change from Baseline in Clinical Global Impression–Severity (CGI-S) score for depressive symptoms •Change from Baseline in Sheehan Disability Scale (SDS) score •Change from Baseline in the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14) score •Change from Baseline in Karolinska Sleepiness Scale (KSS) score ;Timepoint(s) of evaluation of this end point: After final Database lock | — |
Countries
Bulgaria, Czech Republic, Finland, Italy, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs (Alida Barry)
ACADIA Pharmaceuticals Inc
Outcome results
None listed