- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01517360
Pharmacological Approach to Improve the Outcome of Social Cognition Training
연구 개요
상세 설명
Individuals with schizophrenia often have serious deficits in their abilities to perceive and interpret socially relevant information. These deficits in social cognition can lead to misunderstanding the intentions of others and failing to interpret social signals that are important for successful social interactions. The relationship between social cognition and functioning has led our group to develop a research agenda that includes understanding the neural underpinnings of social cognitive deficits, measuring these impairments using brain-based biomarkers and clinical assessments, and enhancing our Social Cognitive Skills Training program to improve social cognition and promote recovery.
Oxytocin, which is a hormone and neurotransmitter, is believed to impact social cognition through increased orienting toward and attending to socially salient visual features. There is also evidence that oxytocinergic signaling is impaired in schizophrenia. With this research, we hope to learn whether administration of oxytocin will improve different aspects of social cognition by examining the effects of oxytocin versus placebo administered intranasally before each of 12 sessions of a social cognitive skills training program on measures of independent living, work and social functioning.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90073
- West Los Angeles VA Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition
- Stable on an antipsychotic medication
- No change in antipsychotic dose of >10% during the past 3 months
Exclusion Criteria:
- Unable to provide informed consent
- History of epilepsy
- Active medical conditions that would make the study unsafe
- History of serious head injury
- History of hyponatremia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Placebo+Social Cognitive Skills Training
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
The treatment groups will include individuals who are assigned to placebo.
Each training session will last for about 90 minutes (1 hour training and 30 minutes between placebo administration and start of training).
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Placebo, matched to Oxytocin, intranasal inhalation
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).
|
실험적: Oxytocin+Social Cognitive Skill Training
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
The treatment groups will include individuals who are assigned to oxytocin.
Each training session will last 90 minutes (1 hour training and 30 minutes between oxytocin administration and start of training).
|
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).
Oxytocin 40 IU, intranasal inhalation
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Composite Social Cognition Score
기간: Baseline, 6 weeks, and 10 weeks
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We will assess emotion management, emotion perception, social context processing/social perception, theory of mind, attributional bias, and empathic accuracy.
The primary summary measure for each test will be mean-centered and standardized to create a Z-score that will be averaged to create a single composite score for social cognition, serving as the primary outcome measure.
Parallel follow-up analyses will be conducted on individual components to determine which measures are most affected by treatment.
Similar secondary analyses will be employed for the event related potential (ERP) and basic cognition measures.
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Baseline, 6 weeks, and 10 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Stephen R Marder, MD, Department of Veterans Affairs, University of California Los Angeles
간행물 및 유용한 링크
일반 간행물
- Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7.
- Marder SR, Wirshing WC, Mintz J, McKenzie J, Johnston K, Eckman TA, Lebell M, Zimmerman K, Liberman RP. Two-year outcome of social skills training and group psychotherapy for outpatients with schizophrenia. Am J Psychiatry. 1996 Dec;153(12):1585-92. doi: 10.1176/ajp.153.12.1585.
- Horan WP, Kern RS, Tripp C, Hellemann G, Wynn JK, Bell M, Marder SR, Green MF. Efficacy and specificity of social cognitive skills training for outpatients with psychotic disorders. J Psychiatr Res. 2011 Aug;45(8):1113-22. doi: 10.1016/j.jpsychires.2011.01.015. Epub 2011 Mar 4.
- Heinrichs M, von Dawans B, Domes G. Oxytocin, vasopressin, and human social behavior. Front Neuroendocrinol. 2009 Oct;30(4):548-557. doi: 10.1016/j.yfrne.2009.05.005. Epub 2009 Jun 6.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Promise # 0041
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Placebo에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로