- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00922272
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
25 de mayo de 2021 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
92
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72201
- K&S Professional Research Services
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California
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Anaheim, California, Estados Unidos, 92805
- Omega Clinical Trials
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Anaheim, California, Estados Unidos, 92804
- South Coast Clinical Trials
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Costa Mesa, California, Estados Unidos, 92626
- Clinical Innovations
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Garden Grove, California, Estados Unidos, 92845
- Collaborative Neuroscience Network, Inc.
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Long Beach, California, Estados Unidos, 90813
- Apostle Clinical Trials, Inc.
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Oceanside, California, Estados Unidos, 92056
- Excell Research, Inc.
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San Bernardino, California, Estados Unidos, 92405
- Southcoast Clinical Trials
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San Diego, California, Estados Unidos, 92123
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92108
- Affiliated Research Institute
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San Diego, California, Estados Unidos, 92102
- CNRI San Diego & Los Angeles
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Santa Ana, California, Estados Unidos, 92701
- Neuropsychiatric Research Center of Orange County
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Florida
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Kissimmee, Florida, Estados Unidos, 34741
- Accurate Clinical Trials
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Lauderhill, Florida, Estados Unidos, 33319
- Behavioral Clinical Research, Inc
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North Miami, Florida, Estados Unidos, 33161
- Segal Institute for Clinical Research (Miami)
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Orange City, Florida, Estados Unidos, 32763
- Medical Research Group of Central Florida
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Tampa, Florida, Estados Unidos, 33613
- Stedman Clinical Trials
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Georgia
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Atlanta, Georgia, Estados Unidos, 30328
- Comprehensive Neuroscience
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Illinois
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Chicago, Illinois, Estados Unidos, 60640
- Uptown Research Institute
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71104
- J. Gary Booker, MD, APMC
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New Jersey
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Willingboro, New Jersey, Estados Unidos, 08046
- CRI Worldwide, LLC.
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New York
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Elmsford, New York, Estados Unidos, 10523
- Advanced Bio-Behavioral Sciences
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Hollis, New York, Estados Unidos, 11423
- Comprehensive NeuroScience, Inc.
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19139
- CRI Worldwide
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Texas
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Austin, Texas, Estados Unidos, 78756
- Community Clinical Research, Inc.
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Irving, Texas, Estados Unidos, 75062
- University Hills Clinical Research
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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oral, once daily
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Experimental: SPD489 (Lisdexanfetamina dimesilato)
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oral, 20, 30, 40, 50, 60, or 70 mg once daily
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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)
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
Periodo de tiempo: Double-blind Randomization Baseline and Week 4 Double-blind Phase
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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.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Periodo de tiempo: Week 10 Open-label Phase
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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.
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Week 10 Open-label Phase
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Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
Periodo de tiempo: Week 4 Double-blind Phase
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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.
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Week 4 Double-blind Phase
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Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Randomization Baseline and Week 4 Double-blind Phase
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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.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF
Periodo de tiempo: 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.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline
Periodo de tiempo: Open-label Baseline
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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)
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Open-label Baseline
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Percent of Participants With CGI-S at Week 10 Open-label Phase
Periodo de tiempo: Week 10 Open-label Phase
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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)
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Week 10 Open-label Phase
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Percent of Participants With CGI-S at Double-blind Randomization Baseline
Periodo de tiempo: Double-blind Randomization Baseline
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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)
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Double-blind Randomization Baseline
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Percent of Participants With CGI-S at Week 4 Double-blind Phase
Periodo de tiempo: Week 4 Double-blind Phase
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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)
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Week 4 Double-blind Phase
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Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase
Periodo de tiempo: Open-label Phase Week 10
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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.
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Open-label Phase Week 10
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Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Phase Week 4
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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.
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Double-blind Phase Week 4
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Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and week 10 Open-label Phase
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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.
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Open-label Baseline and week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Randomization Baseline and Week 4
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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.
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Double-blind Randomization Baseline and Week 4
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Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and week 10 Open-label Phase
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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.
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Open-label Baseline and week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Randomization Baseline and Week 4
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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.
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Double-blind Randomization Baseline and Week 4
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Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10
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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.
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Open-label Baseline and Week 10
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Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Randomization Baseline and week 4 Double-blind Phase
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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.
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Double-blind Randomization Baseline and week 4 Double-blind Phase
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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
Periodo de tiempo: Open-label Baseline and week 10 Open-label Phase
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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.
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Open-label Baseline and week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase
Periodo de tiempo: 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.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Randomization Baseline and Week 4 Double-blind Phase
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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.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase
Periodo de tiempo: 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.
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Open-label Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and week 10 Open-label Phase
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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.
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Open-label Baseline and week 10 Open-label Phase
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Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase
Periodo de tiempo: 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.
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Open-label Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase
Periodo de tiempo: Double-blind Randomization Baseline and Week 4 Double-blind Phase
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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.
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Double-blind Randomization Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase
Periodo de tiempo: Open-label Baseline and Week 4 Double-blind Phase
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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.
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Open-label Baseline and Week 4 Double-blind Phase
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Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase
Periodo de tiempo: Open-label Baseline and Week 10 Open-label Phase
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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.
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Open-label Baseline and Week 10 Open-label Phase
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Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase
Periodo de tiempo: Open-label Baseline and Week 4 of Double-blind Phase
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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.
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Open-label Baseline and Week 4 of Double-blind Phase
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de septiembre de 2009
Finalización primaria (Actual)
20 de enero de 2011
Finalización del estudio (Actual)
20 de enero de 2011
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2009
Primero enviado que cumplió con los criterios de control de calidad
16 de junio de 2009
Publicado por primera vez (Estimar)
17 de junio de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de junio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
25 de mayo de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Esquizofrenia
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de dopamina
- Inhibidores de la captación de dopamina
- Estimulantes del Sistema Nervioso Central
- Dimesilato de lisdexanfetamina
Otros números de identificación del estudio
- SPD489-204
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre SPD489 (lisdexamfetamine dimesylate)
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ShireTerminadoTrastorno por déficit de atención con hiperactividad (TDAH)Estados Unidos
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ShireTerminadoTrastorno depresivo mayorEstados Unidos, Chile, Australia, Argentina, Reino Unido
-
ShireTerminado
-
ShireTerminadoLa privación del sueñoEstados Unidos
-
ShireTerminadoTrastorno por déficit de atención con hiperactividad (TDAH)Estados Unidos
-
ShireRetiradoSíntomas negativos de la esquizofrenia
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ShireTerminado
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ShireTerminadoSaludableEstados Unidos
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ShireTerminadoTDAH específicamente con deterioro de la función ejecutivaEstados Unidos
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ShireTerminadoTrastorno por atracónEstados Unidos, España, Alemania, Canadá, Suecia