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临床试验/NCT00333177
NCT00333177已完成4 期

Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
92
试验地点
1
主要终点
Average Medication Non-adherence

研究概览

简要总结

This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.

详细描述

Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. These symptoms make it difficult to maintain a job, participate in school, and keep up self-care. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. Antipsychotic medications, such as risperidone, and psychosocial treatments, such as cognitive enhancement training and health behavior training, are common, effective treatments for schizophrenia. This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.

Participants in this open label study will be randomly assigned to receive one of the following four combinations of an antipsychotic medication and a psychosocial treatment: cognitive enhancement training plus oral risperidone; cognitive enhancement training plus long-acting injectable risperidone; health behavior training plus oral risperidone; or health behavior training plus long-acting injectable risperidone. Cognitive enhancement training will entail 2 hours per week of computer-assisted training targeted at improving attention, memory, and problem-solving skills. Additionally, participants will attend a weekly 1-hour group meeting to learn how to apply these skills to work and school situations. Health behavior training will involve 3 hours per week of relaxation training, nutrition education, and physical exercise to enhance wellness. Participants assigned to receive oral risperidone will receive their medication in pill form at the dosage determined to be optimal by the study psychiatrist. Participants assigned to receive injectable risperidone will be given one injection every 2 weeks. Dosages will start at 25 mg per injection and will be adjusted as needed.

Treatment will continue for 1 year following dosage stabilization, which typically occurs 2 to 3 months following study entry. For the first 6 months, participants assigned to receive health behavior training will attend study visits once a week and participants assigned to receive cognitive enhancement training will attend study visits once a week. For the final 6 months, all participants will attend study visits twice weekly. At each visit, participants will receive their assigned psychosocial treatment; attend group therapy; meet with a case manager for counseling and assessment of symptoms, work functioning, and social functioning; and meet with a psychiatrist to monitor medication response. Additional cognitive and health behavior measures will be taken every 6 months to assess treatment effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
  • First major episode of psychotic symptoms occurred within 2 years prior to study entry

排除标准

  • Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
  • Mental retardation (e.g., premorbid intelligence quotient (IQ) less than 70)
  • Significant alcohol or substance use during last 6 months
  • Unable to complete research measures in English
  • Any condition that may make risperidone use medically inadvisable

研究组 & 干预措施

Cog Remediation, risperidone injection

Experimental

Participants will receive cognitive remediation training plus risperidone, administered via injection.

干预措施: Cognitive remediation training (CT) (Behavioral)

Cog Remediation, risperidone injection

Experimental

Participants will receive cognitive remediation training plus risperidone, administered via injection.

干预措施: Risperidone, administered via injection (RLAI) (Drug)

Healthy Behavior Training, risperidone injection

Active Comparator

Participants will receive health behavior training plus risperidone, administered via injection.

干预措施: Healthy behavior training (HBT) (Behavioral)

Healthy Behavior Training, risperidone injection

Active Comparator

Participants will receive health behavior training plus risperidone, administered via injection.

干预措施: Risperidone, administered via injection (RLAI) (Drug)

Cog Remediation, oral risperidone

Experimental

Participants will receive cognitive remediation training plus risperidone administered orally.

干预措施: Cognitive remediation training (CT) (Behavioral)

Cog Remediation, oral risperidone

Experimental

Participants will receive cognitive remediation training plus risperidone administered orally.

干预措施: Risperidone, administered orally (Oral Ris) (Drug)

Healthy Behavior Training, oral risperidone

Active Comparator

Participants will receive health behavior training plus risperidone administered orally.

干预措施: Healthy behavior training (HBT) (Behavioral)

Healthy Behavior Training, oral risperidone

Active Comparator

Participants will receive health behavior training plus risperidone administered orally.

干预措施: Risperidone, administered orally (Oral Ris) (Drug)

结局指标

主要结局

Average Medication Non-adherence

时间窗: Averaged over study participation (up to 12 months)

5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

时间窗: Measured at baseline and 12 months

Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.

Work/School Functioning (Global Functioning Scale: Role)

时间窗: Baseline to 12 months

Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.

次要结局

  • Work Behavior Inventory (WBI) Quality of Work/School Performance(Baseline to 1 year)
  • Maintenance of Work/School Attendance(12 months)
  • Retention in Treatment(12 months)
  • Change in Coping Strategies(Baseline to 12 months)
  • Exacerbation or Relapse of Psychotic Symptoms(Occurence after randomization and until end of study participation (up to 12 mos.))
  • Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)(12 months after randomization)
  • Change in Motivation for Work/School(Baseline to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keith Nuechterlein, Ph.D.

Prinicipal Investigator

University of California, Los Angeles

研究点 (1)

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