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SchizophreniaPhase 3NCT02970292

Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

A Phase 3 study testing Pimavanserin in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 105 sites in 10 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 with adjunctive placebo in the treatment of schizophrenia Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
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
396 participants
Where
105 sitesin 10 countries
Study dates
26 Oct 2016to 25 Jun 2019
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults patients, between 18 and 55 years of age
  • A clinical diagnosis of schizophrenia with a minimum duration of 1 year
  • The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
  • Aripiprazole
  • Aripiprazole long-acting injectables:
  • Abilify Maintena®
Show all 16Show fewer
  • Aristada®
  • Risperidone
  • Risperidone long-acting injection
  • Olanzapine
  • Lurasidone
  • Cariprazine
  • Brexpiprazole
  • Asenapine
  • Has had a partial but inadequate response to antipsychotic treatment
  • Has a history of response to antipsychotic treatment other than clozapine

Who cannot join

  • Patient has a psychiatric disorder other than schizophrenia
  • Patient has a history of resistance to antipsychotic treatment
  • A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana
  • Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
  • Patient has current evidence of a serious and/or unstable psychiatric, 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 had a myocardial infarction in the last six months
  • Patient is taking a medication or drug that prolongs the QT interval or has a family or personal 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).

Trial locations and contacts

105 sites in 10 countries.

105 sites in 10 countries

United States33 sites

  • Study site

    Ann Arbor, Michigan, 48105

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Atlanta, Georgia, 30331

  • Study site

    Bellflower, California, 90706

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Boca Raton, Florida, 33431

  • Study site

    Catonsville, Maryland, 21228

  • Study site

    Cedarhurst, New York, 11516

  • Study site

    Cerritos, California, 90703

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Charlotte, North Carolina, 28211

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Culver City, California, 90230

  • Study site

    Dayton, Ohio, 45417

  • Study site

    Hoffman Estates, Illinois, 60169

  • Study site

    Jamaica, New York, 11432

  • Study site

    Lake Charles, Louisiana, 70629

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Lauderhill, Florida, 33319

  • Study site

    Lemon Grove, California, 91945

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Long Beach, California, 90822

  • Study site

    Miami, Florida, 33122

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Richardson, Texas, 75080

  • Study site

    Rochester, New York, 14618

  • Study site

    Rogers, Arkansas, 72758

  • Study site

    Salt Lake City, Utah, 84105

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92123

  • Study site

    Santa Ana, California, 92705

  • Study site

    Torrance, California, 90502

Other trials in United States

Russia15 sites

  • Study site

    Arkhangelsk, 163530

  • Study site

    Moscow, 115522

  • Study site

    Plekhanovo, Lipetsk Oblast, 399313

  • Study site

    Roshchino, Leningradskaya Oblast', 188820

  • Study site

    Saint Petersburg, 190121

  • Study site

    Saint Petersburg, 192019

  • Study site

    Saint Petersburg, 193167

  • Study site

    Saint Petersburg, 195112

  • Study site

    Saint Petersburg, 197341

  • Study site

    Samara, 443016

  • Study site

    Smolensk, 214019

  • Study site

    Stavropol, 355038

  • Study site

    Tonnel’nyy, Stavropol Kray, 357034

  • Study site

    Voronezh, 394024

  • Study site

    Yaroslavl, 150003

Other trials in Russia

Bulgaria14 sites

  • Study site

    Burgas, 8000

  • Study site

    Pazardzhik, 4400

  • Study site

    Plovdiv, 4000

  • Study site

    Sofia, 1202

  • Study site

    Sofia, 1408

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1680

  • Study site

    Targovishte, 7700

  • Study site

    Tserova Koria, 5047

  • Study site

    Varna, 9020

  • Study site

    Veliko Tarnovo, 5000

  • Study site

    Veliko Tarnovo, 5047

  • Study site

    Vratsa, 3000

Other trials in Bulgaria

Ukraine14 sites

  • Study site

    Dnipro, 49005

  • Study site

    Hlevakha, 08631

  • Study site

    Kharkiv, 61068

  • Study site

    Kherson, Vil. Stepanivka, 73488

  • Study site

    Kyiv, 01133

  • Study site

    Kyiv, 02192

  • Study site

    Kyiv, 04080

  • Study site

    Kyiv, 08631

  • Study site

    Odesa, 65014

  • Study site

    Oleksandrivka, 67513

  • Study site

    Poltava, 36013

  • Study site

    Smila, 08631

  • Study site

    Smila, 20708

  • Study site

    Vinnytsia, 21005

Other trials in Ukraine

Czechia6 sites

  • Study site

    Hradec Králové, 503 41

  • Study site

    Pilsen, 312 00

  • Study site

    Prague, 100 00

  • Study site

    Prague, 106 00

  • Study site

    Prague, 160 00

  • Study site

    Říčany, 251 01

Other trials in Czechia

Hungary5 sites

  • Study site

    Budapest, Pest County, 1036

  • Study site

    Budapest, Pest County, 1083

  • Study site

    Debrecen, 4032

  • Study site

    Kalocsa, Bács-Kiskun Megya, 6300

  • Study site

    Pécs, 7633

Other trials in Hungary

Lithuania5 sites

  • Study site

    Kaunas, 44279

  • Study site

    Kaunas, 48259

  • Study site

    Kaunas, 50185

  • Study site

    Šilutė, 99142

  • Study site

    Vilnius, 09112

Other trials in Lithuania

Poland5 sites

  • Study site

    Bialystok, 15 756

  • Study site

    Bydgoszcz, 85 080

  • Study site

    Lublin, 20 080

  • Study site

    Lublin, 20 582

  • Study site

    Pruszcz Gdański, 83 000

Other trials in Poland

Serbia5 sites

  • Study site

    Belgrade, 11 000

  • Study site

    Belgrade, 11000

  • Study site

    Kovin, 26 220

  • Study site

    Kragujevac, 34 000

  • Study site

    Niš, 18 000

Other trials in Serbia

Canada3 sites

  • Study site

    Chatham, Ontario, N7L1C1

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Toronto, M6J 1H4

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia

Conditions
Schizophrenia
Being tested
Pimavanserin, Placebo
Medical subject headings
Schizophrenia

What participants receive

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

  • PimavanserinDrug

    Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth

  • PlaceboDrug

    Placebo, taken as two tablets, once daily by mouth

Study groups in NCT02970292
Study groupRoleWhat they receive
PimavanserinExperimentalDrug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
Receives: Drug: Pimavanserin
PlaceboPlacebo comparatorPlacebo + background antipsychotic, taken as two tablets, once daily by mouth
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 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

    The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.

    Measured: From baseline to Week 6

Secondary outcomes (8)

  1. Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score

    The CGI-S 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-S score denotes greater severity of the disorder.

    Measured: From baseline to Week 6

  2. Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score

    The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme).

    The PANSS positive subscale score can range from 7 to 49; the PANSS negative subscale score can range from 7 to 49; the PANSS general psychopathology scale score can range from 16 to 112.

    For each of the subscale scores, a higher score signifies greater severity of schizophrenia symptoms.

    Measured: From baseline to Week 6

  3. PANSS Responders

    Porportion of patients showing a PANSS response of >=20% or >=30% reduction in PANSS total score PANSS total score reduction signifies improvement.

    Measured: From baseline to Week 6

  4. Clinical Global Impression-Improvement (CGI-I) Response

    The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.

    A CGI-I score of 1 or 2 was counted as response. The Analysis was performed twice; once including missing values as non-responders (MN) and once including only observed cases (OC).

    Measured: From baseline to Week 6

  5. Clinical Global Impression-Improvement (CGI-I) Score at Week 6

    The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.

    Measured: From baseline to Week 6

  6. Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score

    The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of patients with schizophrenia. The maximum score is 100. Higher scores denote better psychosocial functioning.

    Measured: From baseline to Week 6

  7. Drug Attitude Inventory (DAI-10)

    The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a patient who is fully adherent to study medication would answer as "True" and 4 items (2, 5, 6, and 8) that a patient who is fully adherent to study medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1; the total score is derived as overall sum. The score can range from -10 to 10. Positive total scores indicate adherence and negative total scores indicate non-adherence. Higher scores denote better adherence.

    Measured: From baseline to Week 6

  8. Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score

    The KSS is a self-reported measure of a patient's level of drowsiness. In this study, drowsiness was to be rated during the last week (7 days). Scoring is based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). The maximum score is 9. Higher scores denote more drowsiness.

    Measured: From baseline to Week 6

Timeline

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

  1. First posted22 Nov 2016 (estimated)
  2. Study start26 Oct 2016
  3. Primary completion28 May 2019
  4. Study completion25 Jun 2019

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
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02970292
Sponsor's protocol ID
ACP-103-034
Other IDs
2016-003434-24, 2016
Status last verified
May 2020
First submitted
18 Nov 2016
Last updated
17 Jun 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bugarski-Kirola D, Abbs B, Odetalla R, Liu IY, Darwish M, DeKarske D. Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies. Patient Prefer Adherence. 2024 Jan 19;18:207-216. doi: 10.2147/PPA.S436041. eCollection 2024.

    PubMed 38264323

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimavanserin in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 105 sites in 10 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 16 inclusion and 8 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Russia, Bulgaria, Ukraine, Czechia and 5 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 Jun 2020). 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 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: From baseline to Week 6). 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 NCT02970292, which also lists 1 linked publication.

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 Jun 2020.

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