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Trial record 2 of 3 for:    pimavanserin | major depressive disorder | Phase 3

Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT03999918
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adjunctive Treatment of Major Depressive Disorder Drug: Pimavanserin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Drug - pimavanserin
Pimavanserin 34 mg tablets
Drug: Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily

Placebo Comparator: Placebo
Placebo tablets
Drug: Placebo
Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily




Primary Outcome Measures :
  1. Change from Baseline in the Hamilton Depression Scale (17 items) (HAMD-17) total score [ Time Frame: 6 Weeks Treatment Duration ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline in Sheehan Disability Scale (SDS) score [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  2. Change from Baseline in Clinical Global Impression-Severity (CGI-S) score for depressive symptoms [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  3. Clinical Global Impression-Improvement (CGI-I) score for depressive symptoms [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  4. Change from Baseline in the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14) [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  5. Change from Baseline in Karolinska Sleepiness Scale (KSS) score [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  6. • Treatment responder rates. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  7. • Treatment remission rates. Treatment remission is defined as a HAMD-17 total score ≤7. [ Time Frame: 6 Weeks Treatment Duration ]
    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 remission is defined as a HAMD-17 total score ≤7.

  8. Change from Baseline in the Hamilton Depression (HAMD) Anxiety/Somatization factor score [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  9. Change from Baseline in the Barratt Impulsiveness Scale (BIS-11) [ Time Frame: 6 Weeks Treatment Duration ]
    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.

  10. Change from Baseline to Week 1 in the HAMD-17 total score [ Time Frame: 1 week (6 Weeks Total Treatment Duration) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients, aged 18 years and above
  2. A clinical diagnosis of major depressive disorder (MDD)
  3. Is being treated with one of the following SSRI or SNRI antidepressants:

    1. Citalopram
    2. Escitalopram
    3. Paroxetine
    4. Fluoxetine
    5. Sertraline
    6. Duloxetine
    7. Venlafaxine
    8. Desvenlafaxine
    9. Venlafaxine XR
  4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
  5. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

  1. Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
  2. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
  3. Has a known history or symptoms of long QT syndrome
  4. Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999918


Contacts
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Contact: Becky Howell 609-250-6923 bhowell@ACADIA-Pharm.com
Contact: Jim Harlick 250-382-5265 JHarlick@acadia-pharm.com

Locations
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Finland
ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.) Recruiting
Helsinki, Finland, 00100
Savon Psykiatripalvelu Oy Recruiting
Kuopio, Finland, 70110
Oulu Mentalcare Oy Recruiting
Oulu, Finland, 90100
Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori Recruiting
Pori, Finland, 28130
Psykiatri- ja psykologikeskus Mentoria Recruiting
Tampere, Finland, 33200
Poland
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski Recruiting
Bełchatów, Poland, 97-400
Przychodnia Śródmieście Sp. z o.o. Recruiting
Bydgoszcz, Poland, 85-080
Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała Recruiting
Gdańsk, Poland, 80-438
Nzop Mentis Recruiting
Leszno, Poland, 64-100
Neurologiczny NZOZ im. dr n. med. Hanki Recruiting
Plewiska, Poland, 62-064
Zachodniopomorski Instytut Psychoterapii Recruiting
Szczecin, Poland, 70-480
Russian Federation
Samara Psychiatric Hospital Recruiting
Samara, Russian Federation, 443016
Regional Clinical Psychiatric Hospital of St. Sofia Recruiting
Saratov, Russian Federation, 410060
St. Nicholas the Wonder Worker Psychiatric Hospital Recruiting
St. Petersburg, Russian Federation, 190121
Psychoneurological Dispensary # 5 Recruiting
St. Petersburg, Russian Federation, 195176
City Narcology Hospital Recruiting
St. Petersburg, Russian Federation, 199004
LION-MED Recruiting
Voronezh, Russian Federation, 394052
Serbia
Clinical Hospital Center Dr Dragisa Misovic Recruiting
Belgrade, Serbia, 11000
Clinical Centre Nis, Clinic for Psychiatry Gornja Recruiting
Toponica, Serbia, 18202
Slovakia
EPAMED s r.o. Recruiting
Kosice, Slovakia, 040 17
Centrum Zdravia R.B.K., s.r.o. Recruiting
Svidník, Slovakia, 089 01
Ukraine
Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov Recruiting
Dnipro, Ukraine, 49005
Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron" Recruiting
Kharkiv, Ukraine, 61091
Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway" Recruiting
Kyiv, Ukraine, 01030
Odesa Regional Medical Centre of Mental Health Recruiting
Odesa, Ukraine, 65006
Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region, Recruiting
Stepanivka, Ukraine, 73488
Ternopil Regional Communal Clinical Psychoneurological Hospital, psychiatric department # 2 (men), psychiatric department # 6 (women), Ternopil State Medical University n.a. I.Y. Gorbachevskyy, Chair of Psychiatry, Narcology and Medical Psychology Recruiting
Ternopil, Ukraine, 46027
Communal Institution "Vinnytsia Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Department #7 (male), Department #10 (female),Vinnytsia National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeuti Recruiting
Vinnytsya, Ukraine, 21005
United Kingdom
MAC Clinical Research - Blackpool Recruiting
Blackpool, United Kingdom, FY2 0JH
MAC Clinical Research Ltd - Liverpool Recruiting
Liverpool, United Kingdom, L34 1BH
MAC Clinical Research - Manchester Recruiting
Manchester, United Kingdom, M13 9NQ
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03999918     History of Changes
Other Study ID Numbers: ACP-103-054
2018-003251-37 ( EudraCT Number )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pimavanserin
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action