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

25 maggio 2021 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

92

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo matching SPD489 (lisdexamfetamine dimesylate)
oral, once daily
Sperimentale: SPD489 (Lisdexamfetamine dimesylate)
Droga: SPD489 (lisdexamfetamine dimesylate)
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Altri nomi:
  • Vyvanse

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shire

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 settembre 2009

Completamento primario (Effettivo)

20 gennaio 2011

Completamento dello studio (Effettivo)

20 gennaio 2011

Date di iscrizione allo studio

Primo inviato

15 giugno 2009

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2009

Primo Inserito (Stima)

17 giugno 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 maggio 2021

Ultimo verificato

1 maggio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SPD489-204

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sedi

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