Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

24 апреля 2014 г. обновлено: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-blind, Placebo-controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Flexible-dose Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential for drug-drug interaction is particularly important in this patient population, in which multiple drug therapy is relatively common. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo-controlled, parallel-group study is designed to examine the effectiveness and safety of paliperidone ER in adult patients with schizoaffective disorder who are experiencing an acute episode of this disorder. Patients in the study will be randomly assigned to 1 of 2 groups to receive 6 weeks of oral treatment with flexible dosages of paliperidone ER (3-12 mg/day) or with placebo. The primary efficacy outcome will be the change from baseline to Week 6, or the last post-randomization assessment during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs measurements, physical examination, administration of a 12-lead ECG, movement disorders side effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to participate in a pharmacogenomic (DNA) analysis. The primary study hypothesis is that flexible-dose paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or paliperidone ER 6 mg/day. After day 4, dosages may be adjusted, at defined intervals, to a dosage between 3 mg/day and 12 mg/day, inclusive.

Тип исследования

Интервенционный

Регистрация (Действительный)

307

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Индия
      • Ahmedabad, Индия
      • Ahmedibad, Индия
      • Aurangabad, Индия
      • Chennai, Индия
      • Delhi, Индия
      • Kanpur Uttarpradeh, Индия
      • Pune, Индия
      • Vadadora, Индия
  • Корея, Республика
      • Chonju, Корея, Республика
      • Daegu, Корея, Республика
      • Gyeonggi-Do, Корея, Республика
      • Inchun, Корея, Республика
      • Kwangiu, Корея, Республика
      • Pusan, Корея, Республика
      • Seoul, Корея, Республика
  • Малайзия
      • Ipoh, Малайзия
      • Kota Kinabalu, Малайзия
      • Kuala Lumpur, Малайзия
      • Kuching, Малайзия
  • Румыния
      • Arad, Румыния
      • Bucharest, Румыния
      • Campina, Румыния
      • Com Gura Ocnitei, Румыния
      • Iasi, Румыния
      • Pitesti, Румыния
  • Соединенные Штаты
    • California
      • Cerritos, California, Соединенные Штаты
      • Costa Mesa, California, Соединенные Штаты
      • Garden Grove, California, Соединенные Штаты
      • Huntington Beach, California, Соединенные Штаты
      • Pico Rivera, California, Соединенные Штаты
      • San Diego, California, Соединенные Штаты
    • Florida
      • Aventura, Florida, Соединенные Штаты
      • Hollywood, Florida, Соединенные Штаты
      • Kissimmee, Florida, Соединенные Штаты
      • Leesburg, Florida, Соединенные Штаты
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты
    • South Carolina
      • Charleston, South Carolina, Соединенные Штаты
    • Texas
      • Austin, Texas, Соединенные Штаты
      • Irving, Texas, Соединенные Штаты
  • Филиппины
      • Davao City, Филиппины
      • Mandaluyong, Филиппины
      • Manila, Филиппины
      • Pasig National Capitol Region, Филиппины

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
  • A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60
  • A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

Exclusion Criteria:

  • A primary active mental illness diagnosis other than schizoaffective disorder
  • Patients with first episode psychosis
  • Active substance dependence within previous 6 months
  • Treatment with clozapine within 6 months of randomization
  • A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
  • Pregnancy, breast-feeding, or planning to become pregnant

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 001
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Лекарство: Paliperidone ER
(3-12mg/day in 3 mg/day increments for 6 weeks)
Экспериментальный: 003
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Лекарство: Paliperidone ER
(3-12mg/day in 3 mg/day increments for 6 weeks)
Плацебо Компаратор: 002
Placebo for 6 weeks
Лекарство: Placebo
for 6 weeks

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
Временное ограничение: Baseline
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Baseline
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
Временное ограничение: Baseline
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects". Higher scores indicate worsening.
Baseline
Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects". Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
Временное ограничение: Week 6 or the last post-randomization assessment during double-blind treatment
The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to "No change". Ratings of <4 are equivalent to "improvement" and ratings of > 4 are equivalent to "worsening". Higher scores indicate worsening.
Week 6 or the last post-randomization assessment during double-blind treatment
Participants With Response
Временное ограничение: Week 6 LOCF End Point
Response is defined as a 30% or more reduction from baseline PANSS total score and CGI-C score of <= 2 (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder).
Week 6 LOCF End Point

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
Временное ограничение: Baseline
Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.
Baseline
Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
Временное ограничение: Baseline
11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.
Baseline
Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Временное ограничение: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Соавторы

Janssen, LP

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 декабря 2006 г.

Первичное завершение (Действительный)

1 июня 2008 г.

Завершение исследования (Действительный)

1 июня 2008 г.

Даты регистрации исследования

Первый отправленный

15 декабря 2006 г.

Впервые представлено, что соответствует критериям контроля качества

15 декабря 2006 г.

Первый опубликованный (Оценивать)

18 декабря 2006 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

9 мая 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 апреля 2014 г.

Последняя проверка

1 апреля 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CR013099
  • R076477SCA3002

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Paliperidone ER

Искать похожие исследования

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

CROs by country

CROs in France

Заболевания

Редкие заболевания

Медикаментозные вмешательства

Пищевые добавки

Спонсор / Соавторы

Места

Подписаться