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

25 maja 2021 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

92

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 55 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Lek: Placebo matching SPD489 (lisdexamfetamine dimesylate)
oral, once daily
Eksperymentalny: SPD489 (dimezylan lisdeksamfetaminy)
Lek: SPD489 (lisdexamfetamine dimesylate)
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Inne nazwy:
  • Vyvanse

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shire

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 września 2009

Zakończenie podstawowe (Rzeczywisty)

20 stycznia 2011

Ukończenie studiów (Rzeczywisty)

20 stycznia 2011

Daty rejestracji na studia

Pierwszy przesłany

15 czerwca 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2009

Pierwszy wysłany (Oszacować)

17 czerwca 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 czerwca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 maja 2021

Ostatnia weryfikacja

1 maja 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SPD489-204

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na SPD489 (lisdexamfetamine dimesylate)

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