A Randomized, Sham-Controlled Study of PEAR-004 as an Adjunct to Standard-of-care Treatment for Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 7
- 主要终点
- Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
研究概览
简要总结
The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).
The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.
详细描述
This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112 subjects were randomized 1:1 in to the following groups:
- Group A: Clinician-directed pharmacotherapy + PEAR-004
- Group B: Clinician-directed pharmacotherapy + sham app An up to 28-day screening period included standard screening assessments as defined in the assessment schedule. Eligible subjects were randomized on Day 1 into one of the treatment groups.
Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit, standard assessments were performed according to the assessment schedule, including PANSS, ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final follow-up visit was performed at Week 16 (day 115),
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
- •SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60
- •Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
- •Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator
排除标准
- •Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
- •Planning to move out of the geographic area within 3 months
- •Unable to use English to participate in the consent process, the interventions or assessments
- •Inability to comply with study procedures, due to severe medical conditions or otherwise
- •Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
- •Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder in the past 2 months
- •Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or cannabis) in the past 2 months
- •Considered high risk for suicidal behavior based on ISST-Plus score at screening, or in the judgement of the investigator
- •Previously participated in a clinical study involving PEAR-004
结局指标
主要结局
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
时间窗: Baseline, Day 29, Day 57, Day 85
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
Percent of Dropout
时间窗: Day 115
Dropout rate to evaluate retention to assigned study treatment
次要结局
- Number of Patients With Adverse Events(Day 115)
- Number of Patients With Vital Sign Measurements(Day 85)
- Change From Baseline in the Negative PANSS Score(Baseline, Day 29, Day 57, Day 85)
- Change From Baseline in the World Health Organization Quality of Life (WHOQOL-BREF) Scale(Baseline, Day 29, Day 57, Day 85)
- Percentage of Responders as Assessed by the Total PANSS Score(Day 85)
- Change From Baseline in the Positive PANSS Score(Baseline, Day 29, Day 57, Day 85)
- Percentage of Responders as Assessed by the Brief Medication Questionnaire (BMQ)(Day 29, Day 57, and Day 85)
- InterSePT Scale for Suicidal Thinking-Plus (ISST-Plus) Score(Baseline, Day 29, 57, 85, and 115)
- Change From Baseline in the General Psychopathology PANSS Score(Baseline, Day 29, Day 57, Day 85)
- Change From Baseline in the Motivation and Pleasure Self-report (MAP-SR) Score(Baseline, Day 29, Day 57, Day 85)
- Change From Baseline in the Beck Depression Inventory, Second Ed. (BDI-II) Total Score(Baseline, Day 29, Day 57, Day 85)
- Percentage Change From Baseline in Total PANSS Score (Within Assigned Treatment Group)(Baseline, Day 29, Day 57, Day 85)