Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
- Conditions
- Adjunctive Treatment of Major Depressive Disorder
- Interventions
- Other: Placebo
- Registration Number
- NCT03018340
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
-
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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + SSRI/SNRI Placebo Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study. Pimavanserin 34 mg + SSRI/SNRI Pimavanserin Drug- pimavanserin, 34 mg, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 5 in the HAMD-17 Total Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. 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. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4, depending on the item. Items are summed up to calculate the HAMD-17 total score. The total score ranges from 0 to 52. A higher total score indicates more severe depression.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 5 in SF-12 Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The 12-Item Short Form Health Survey is a patient-reported outcome measure that addresses 8 domains of physical functioning, role - physical, bodily pain, general health perceptions, vitality, social functioning, role - emotional, and mental health. Composite scores were obtained representing physical health and mental health composite summaries, Physical Component Summary (PCS) and Mental Component Summary (MCS), respectively. An algorithm was used to generate PCS and MCS for comparison to normative data. In normative data, the mean score was set to 50; thus, scores \>50 indicate better physical or mental health than the mean and scores \<50 indicate worse health. A higher score is indicative of a better health state.
Change From Baseline to Week 5 in DAI-10 Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Drug Attitude Inventory-10 is a 6-item patient-facing questionnaire to evaluate a patient's perceptions and experiences of treatment. It contains 6 items that a patient who is fully adherent to prescribed medication would answer as "True," and 4 items that a patient who is fully adherent would rate as "False." Scores are allocated to each answer and the total score is calculated as the sum. A correct answer is scored +1 and an incorrect answer is scored -1. The total score ranges from -10 to 10 and is the sum of pluses and minuses. A positive total score indicates a positive subjective response (adherent) and a negative total score indicates a negative subjective response (nonadherent). Higher scores denoted better adherence.
Change From Baseline to Week 5 in the SDS Total Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Sheehan Disability Scale is a 3-item patient-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point scale from 0 (no impairment) to 10 (most severe). The total SDS score ranges from 0 to 10. It is calculated as the arithmetic mean of the scores for all 3 items. A higher score indicates greater disability.
Treatment Response and Remission Rates at the End of 5-week Treatment Period Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4 depending on the item. Items are summed up to calculate the HAMD-17 total score. A higher total score indicates more severe depression.
Treatment response was defined as a reduction from Baseline in HAMD-17 total score of \>=50%.
Remission was defined as a HAMD-17 total score \<=7.Change From Baseline to Week 5 in CGI-S Total Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Clinical Global Impression-Severity Scale is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-I score denotes more severe depression.
CGI-I Score at Week 5 Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Clinical Global Impression- Improvement scale is a 1-item scale, used to rate the global improvement of the patient since beginning of the study from 0 (not assessed) to 7 (very much worse). A higher CGI-I score denotes less improvement in depression.
Change From Baseline to Week 5 in KSS Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Karolinska Sleepiness Scale is a patient-facing 1-item scale that measures the patient's drowsiness. Scoring is based on a 9-point verbally anchored scale ranging from "extremely alert" (1) to "very sleepy, great effort to keep awake, fighting sleep" (9). Higher scores denote more drowsiness.
Change From Baseline to Week 5 in MGH-SFI Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Massachusetts General Hospital Sexual Functioning Index is a patient-facing questionnaire that quantifies sexual dysfunction into 5 functional domains ("interest in sex," "sexual arousal," "ability to achieve orgasm," "ability to maintain erection" \[males only\], and "sexual satisfaction"). Patients rate each item using a 6-point scale ranging from 1 (good function) to 6 (poor function). The MGH-SFI score is calculated as the arithmetic mean of the item scores for the 5 domains. The mean MGH-SFI score ranges from a minimum value of 1 to a maximum value of 6. Higher scores denotes worse sexual dysfunction.
Change From Baseline to Week 5 in BIS-11 Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Barratt Impulsiveness Scale-11 is a questionnaire for assessment of the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale from Rarely/Never (1) to Almost Always/Always (4). Items are summed up to calculate the total score. The BIS-11 total score ranges from 30 to 120. Higher scores denotes more impulsiveness.
Change From Baseline to Week 5 in SIS Score Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively The Sheehan Irritability Scale is a 7-item patient-reported outcome measure to measure the frequency, severity, and impairment associated with irritability in psychiatric patients. It includes items on: irritability, frustration, edginess/ impatience/ overreaction, moodiness, anger with self, anger with others, and temper. Items are answered on an 11-point rating scale where higher scores indicated greater severity (0=not at all, 10=extremely). Item responses are summed into a total score (range=0-70). Higher scores mean higher irritability.
Trial Locations
- Locations (34)
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
Altea Research
🇺🇸Las Vegas, Nevada, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
FutureSearch Trials of Dallas, L.P.
🇺🇸Dallas, Texas, United States
UTSW
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
IPC Research
🇺🇸Waukesha, Wisconsin, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
Synergy San Diego
🇺🇸National City, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Torrance, California, United States
Meridien Research
🇺🇸Maitland, Florida, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
CNS Health care (Jacksonville)
🇺🇸Jacksonville, Florida, United States
CNS Health care (Orlando)
🇺🇸Orlando, Florida, United States
Alam Medical Research, INC
🇺🇸Chicago, Illinois, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
KUMC
🇺🇸Wichita, Kansas, United States
St. Louis Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Neuro-Behavioral Clinical Research
🇺🇸Canton, Ohio, United States
UPenn
🇺🇸Philadelphia, Pennsylvania, United States
BTC of Lincoln
🇺🇸Lincoln, Rhode Island, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
Ericksen Research & Development
🇺🇸Clinton, Utah, United States
UAB
🇺🇸Birmingham, Alabama, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Rivus Wellness & Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon)
🇺🇸Portland, Oregon, United States