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Adjunctive Treatment of Major Depressive DisorderPhase 3NCT03968159

Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

A Phase 3 study testing Pimavanserin in people with Adjunctive Treatment of Major Depressive Disorder, run by ACADIA Pharmaceuticals Inc. at 85 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pimavanserin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
298 participants
Where
85 sitesin 9 countries
Study dates
25 Apr 2019to 29 May 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Citalopram
  • Escitalopram
  • Paroxetine
Show all 14Show fewer
  • Fluoxetine
  • Sertraline
  • Duloxetine
  • Venlafaxine
  • Desvenlafaxine
  • Venlafaxine XR
  • Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
  • 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

Who cannot join

  • 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
  • Has current evidence of delirium or 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
  • Has a known history or symptoms of long QT syndrome
  • 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).

Trial locations and contacts

85 sites in 9 countries.

85 sites in 9 countries

United States41 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Synexus Clinical Research

    Atlanta, Georgia, 30328

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35233

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

  • Social Psychiatry Research Institute (SPRI)

    Brooklyn, New York, 11235

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado, 80910

  • CT Clinical Research

    Cromwell, Connecticut, 06416

  • Future Search Trials of Dallas

    Dallas, Texas, 75231

  • Mountain View Clinical Research, Inc.

    Denver, Colorado, 80209

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067

  • CNS Network

    Garden Grove, California, 92845

  • Charak Clinical Research Center

    Garfield Heights, Ohio, 44125

  • Behavioral Research Specialists

    Glendale, California, 91206

  • Clinical Trial of America, LLC

    Hickory, North Carolina, 28601

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Sun Valley Research Center

    Imperial, California, 92251

  • Irvine Clinical Research

    Irvine, California, 92614

  • Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville

    Jacksonville, Florida, 32256

  • Synergy San Diego

    Lemon Grove, California, 91945

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Meridien Research

    Maitland, Florida, 32751

  • Clinical Neuroscience Solutions CNS Healthcare

    Memphis, Tennessee, 38119

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Clinical Trials of America (Monroe, LA)

    Monroe, Louisiana, 71201

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 26464

  • Mount Sinai Hospital

    New York, New York, 10029

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • NRC Research Institute

    Orange, California, 92868

  • CNS Health Care (Orlando)

    Orlando, Florida, 32801

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Collective Medical Research, LLC

    Prairie Village, Kansas, 66208

  • Finger Lake Clinical Research

    Rochester, New York, 14618

  • St. Charles Psychiatric Associates-Midwest Research Group

    Saint Charles, Missouri, 63304

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Adams Clinical

    Watertown, Massachusetts, 02472

  • IPC Research

    Waukesha, Wisconsin, 53188

  • Grayline Research Center

    Wichita Falls, Texas, 76309

Other trials in United States

Russia8 sites

  • Mental Health Research Center, Department #6

    Moscow, 115522

  • St. Nicholas the Wonder Worker Psychiatric Hospital

    Saint Petersburg, 190121

  • Psychoneurological Dispensary # 5

    Saint Petersburg, 195176

  • City Narcology Hospital

    Saint Petersburg, 199004

  • Samara Psychiatric Hospital

    Samara, 443016

  • Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky

    Saratov, 410028

  • Regional Clinical Psychiatric Hospital of St. Sofia

    Saratov, 410060

  • LION-MED

    Voronezh, 394052

Other trials in Russia

Ukraine8 sites

  • Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov

    Dnipro, 49005

  • Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron"

    Kharkiv, 61091

  • Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway"

    Kyiv, 01030

  • Odesa Regional Medical Centre of Mental Health

    Odesa, 65006

  • Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region

    Stepanovka, 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

    Ternopil, 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

    Vinnytsia, 21005

  • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic

    Vinnytsia, 21005

Other trials in Ukraine

Serbia7 sites

  • Clinical Center of Serbia, Clinic for psychiatry

    Belgrade, 11000

  • Clinical Hospital Center Dr Dragisa Misovic

    Belgrade, 11000

  • Special hospital for psychiatric diseases "Kovin"

    Kovin, 26220

  • Clinical Center Kragujevac , Clinic for Psychiatry

    Kragujevac, 34000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Centre for Mental Health Protection, Clinical Center Nis

    Niš, 18000

  • Clinical Centre Nis, Clinic for Psychiatry Gornja

    Toponica, 18202

Other trials in Serbia

Poland6 sites

  • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

    Bełchatów, 97-400

  • Przychodnia Śródmieście Sp. z o.o.

    Bydgoszcz, 85-080

  • Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała

    Gdansk, 80-438

  • Nzop Mentis

    Leszno, 64-100

  • Neurologiczny NZOZ im. dr n. med. Hanki

    Plewiska, 62-064

  • Zachodniopomorski Instytut Psychoterapii

    Szczecin, 70-480

Other trials in Poland

Finland5 sites

  • ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.)

    Helsinki, 00100

  • Savon Psykiatripalvelu Oy

    Kuopio, 70110

  • Oulu Mentalcare Oy

    Oulu, 90100

  • Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori

    Pori, 28130

  • Psykiatri- ja psykologikeskus Mentoria

    Tampere, 33200

Other trials in Finland

South Africa4 sites

  • Cape Trial Centre

    Cape Town, 7530

  • Dr DG Dennis Incorporated Knighton Surgery

    Cape Town, 7708

  • Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center

    Durbanville, 7550

  • Dr GP Bosch Clinical Research

    Pretoria, 0081

Other trials in South Africa

Slovakia3 sites

  • EPAMED s r.o.

    Košice, 040 17

  • Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie

    Liptovský Mikuláš, 031 23

  • Centrum Zdravia R.B.K., s.r.o.

    Svidník, 089 01

Other trials in Slovakia

United Kingdom3 sites

  • MAC Clinical Research - Blackpool

    Blackpool, FY2 0JH

  • MAC Clinical Research Ltd - Liverpool

    Liverpool, L34 1BH

  • MAC Clinical Research - Manchester

    Manchester, M13 9NQ

Other trials in United Kingdom

About this study

Official title: 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 (ACP-103-054/059)

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

Read the detailed description

Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.

This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.

Being tested
Pimavanserin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PimavanserinDrug

    Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily

  • PlaceboDrug

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

Study groups in NCT03968159
Study groupRoleWhat they receive
Drug - pimavanserinExperimentalPimavanserin 34 mg tablets
Receives: Drug: Pimavanserin
PlaceboPlacebo comparatorPlacebo tablets
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score

    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.

    Measured: Baseline, Week 5

Secondary outcomes (9)

  1. Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms

    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.

    Measured: Baseline, 5 weeks

  2. Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score

    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.

    Measured: Baseline, 5 weeks

  3. Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form

    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.

    Measured: Baseline, 5 weeks

  4. Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score

    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.

    Measured: Baseline, 5 weeks

  5. Change From Baseline to Week 1 in the HAMD-17 Total Score

    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.

    Measured: Baseline, 1 week

  6. Treatment Responder and Treatment Remission Rates at Week 5

    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.

    Measured: Baseline, 5 weeks

  7. Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score

    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.

    Measured: Baseline, 5 weeks

  8. Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)

    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.

    Measured: Baseline, 5 weeks

  9. Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5

    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.

    Measured: Baseline, 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start25 Apr 2019
  3. Primary completion30 Apr 2020
  4. Study completion29 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03968159
Sponsor's protocol ID
ACP-103-054/059
Other IDs
2018-003251-37, 2018
Status last verified
Oct 2021
First submitted
13 May 2019
Last updated
17 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimavanserin in people with Adjunctive Treatment of Major Depressive Disorder, run by ACADIA Pharmaceuticals Inc. at 85 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Russia, Ukraine, Serbia, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score (time frame: Baseline, Week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03968159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.

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