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Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

tiistai 25. toukokuuta 2021 päivittänyt: Shire

A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication

To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

92

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Arkansas
      • Little Rock, Arkansas, Yhdysvallat, 72201
        • K&S Professional Research Services
    • California
      • Anaheim, California, Yhdysvallat, 92805
        • Omega Clinical Trials
      • Anaheim, California, Yhdysvallat, 92804
        • South Coast Clinical Trials
      • Costa Mesa, California, Yhdysvallat, 92626
        • Clinical Innovations
      • Garden Grove, California, Yhdysvallat, 92845
        • Collaborative Neuroscience Network, Inc.
      • Long Beach, California, Yhdysvallat, 90813
        • Apostle Clinical Trials, Inc.
      • Oceanside, California, Yhdysvallat, 92056
        • Excell Research, Inc.
      • San Bernardino, California, Yhdysvallat, 92405
        • Southcoast Clinical Trials
      • San Diego, California, Yhdysvallat, 92123
        • Artemis Institute for Clinical Research
      • San Diego, California, Yhdysvallat, 92108
        • Affiliated Research Institute
      • San Diego, California, Yhdysvallat, 92102
        • CNRI San Diego & Los Angeles
      • Santa Ana, California, Yhdysvallat, 92701
        • Neuropsychiatric Research Center of Orange County
    • Florida
      • Kissimmee, Florida, Yhdysvallat, 34741
        • Accurate Clinical Trials
      • Lauderhill, Florida, Yhdysvallat, 33319
        • Behavioral Clinical Research, Inc
      • North Miami, Florida, Yhdysvallat, 33161
        • Segal Institute for Clinical Research (Miami)
      • Orange City, Florida, Yhdysvallat, 32763
        • Medical Research Group of Central Florida
      • Tampa, Florida, Yhdysvallat, 33613
        • Stedman Clinical Trials
    • Georgia
      • Atlanta, Georgia, Yhdysvallat, 30328
        • Comprehensive Neuroscience
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60640
        • Uptown Research Institute
    • Louisiana
      • Shreveport, Louisiana, Yhdysvallat, 71104
        • J. Gary Booker, MD, APMC
    • New Jersey
      • Willingboro, New Jersey, Yhdysvallat, 08046
        • CRI Worldwide, LLC.
    • New York
      • Elmsford, New York, Yhdysvallat, 10523
        • Advanced Bio-Behavioral Sciences
      • Hollis, New York, Yhdysvallat, 11423
        • Comprehensive NeuroScience, Inc.
    • Ohio
      • Cincinnati, Ohio, Yhdysvallat, 45219
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat, 19139
        • CRI Worldwide
    • Texas
      • Austin, Texas, Yhdysvallat, 78756
        • Community Clinical Research, Inc.
      • Irving, Texas, Yhdysvallat, 75062
        • University Hills Clinical Research

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 55 vuotta (Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Adults aged 18-55
  • Clinically stable Schizophrenia and predominant negative symptoms
  • Taking a stable dose of antipsychotic medication

Exclusion Criteria:

  • Clinically notable positive symptoms defined by PANSS

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Plasebo
Lääke: Placebo matching SPD489 (lisdexamfetamine dimesylate)
oral, once daily
Kokeellinen: SPD489 (lisdeksamfetamiinidimesylaatti)
Lääke: SPD489 (lisdexamfetamine dimesylate)
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Muut nimet:
  • Vyvanse

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
Aikaikkuna: Double-blind Randomization Baseline and Week 4 Double-blind Phase
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Double-blind Randomization Baseline and Week 4 Double-blind Phase

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Aikaikkuna: Week 10 Open-label Phase
Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Week 10 Open-label Phase
Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
Aikaikkuna: Week 4 Double-blind Phase
Response is defined as reduction in total SANS score of greater than or equal to 20%. The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Week 4 Double-blind Phase
Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and Week 4 Double-blind Phase
The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF
Aikaikkuna: Double-blind Randomization Baseline and Week 4 Double-blind Phase
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline
Aikaikkuna: Open-label Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Open-label Baseline
Percent of Participants With CGI-S at Week 10 Open-label Phase
Aikaikkuna: Week 10 Open-label Phase
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Week 10 Open-label Phase
Percent of Participants With CGI-S at Double-blind Randomization Baseline
Aikaikkuna: Double-blind Randomization Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Double-blind Randomization Baseline
Percent of Participants With CGI-S at Week 4 Double-blind Phase
Aikaikkuna: Week 4 Double-blind Phase
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Week 4 Double-blind Phase
Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase
Aikaikkuna: Open-label Phase Week 10
CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Open-label Phase Week 10
Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Phase Week 4
CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Double-blind Phase Week 4
Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and week 10 Open-label Phase
BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.
Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and Week 4
BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.
Double-blind Randomization Baseline and Week 4
Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and week 10 Open-label Phase
LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.
Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and Week 4
LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.
Double-blind Randomization Baseline and Week 4
Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10
HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.
Open-label Baseline and Week 10
Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and week 4 Double-blind Phase
HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.
Double-blind Randomization Baseline and week 4 Double-blind Phase
Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF
Aikaikkuna: Open-label Baseline and week 10 Open-label Phase
UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.
Open-label Baseline and week 10 Open-label Phase
Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and Week 4 Double-blind Phase
UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and Week 4 Double-blind Phase
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase
Aikaikkuna: Open-label Baseline and Week 4 Double-blind Phase
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and week 10 Open-label Phase
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Open-label Baseline and week 10 Open-label Phase
Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase
Aikaikkuna: Open-label Baseline and Week 4 Double-blind Phase
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase
Aikaikkuna: Double-blind Randomization Baseline and Week 4 Double-blind Phase
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase
Aikaikkuna: Open-label Baseline and Week 4 Double-blind Phase
PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Open-label Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase
Aikaikkuna: Open-label Baseline and Week 10 Open-label Phase
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Open-label Baseline and Week 10 Open-label Phase
Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase
Aikaikkuna: Open-label Baseline and Week 4 of Double-blind Phase
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Open-label Baseline and Week 4 of Double-blind Phase

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Shire

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 14. syyskuuta 2009

Ensisijainen valmistuminen (Todellinen)

Torstai 20. tammikuuta 2011

Opintojen valmistuminen (Todellinen)

Torstai 20. tammikuuta 2011

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 15. kesäkuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 16. kesäkuuta 2009

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 17. kesäkuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 9. kesäkuuta 2021

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 25. toukokuuta 2021

Viimeksi vahvistettu

Lauantai 1. toukokuuta 2021

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • SPD489-204

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset SPD489 (lisdexamfetamine dimesylate)

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