"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
研究概览
简要总结
The study wishes to examine whether "extended" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects.
Participants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50/50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing.
This study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office.
The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
详细描述
This is a randomized, double-blind, controlled trial that will compare ED, i.e. alternate day dosing to daily dosing i.e. TAU.
Individuals will be randomized to ED or TAU using a permuted block design with a random number generator. The size will be fixed and study personnel blinded to the randomization block size.
To maintain a double-blind design, our pharmacy will provide, on an individualized basis, APs at the appropriate dose and placebo where necessary in matching gelatin capsules, packaged in blister packs. The active tablet will be over-encapsulated, and matching placebo will be prepared using the same capsules (filled with lactose). Thus, from the individual subject's position, AP treatment is continued according to the same daily schedule. Further, if their current medication is prescribed in divided doses, this too will be employed during the study. The minimum and maximum doses for Risperidone will be 1 mg and 16mg respectively. The minimum and maximum doses for Olanzapine will be 5 mg and 20mg respectively. The minimum and maximum doses for Paliperidone will be 3 mg and 12mg respectively. Other psychotropic medications prescribed before the study will be permitted, with any changes in dosing during its course documented
The trial is 1 year in duration. To prevent bias, the study code will remain blinded until the trial's completion.
Study visits will be scheduled every 2 weeks over the first 6 months, in line with the earlier investigation. Thereafter, the visits will be decreased to every 4 weeks, aligning with the schedule routinely observed in our ambulatory clinics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) A primary diagnosis of a Schizophrenia Spectrum or Other Psychotic Disorder as defined by the DSM-5 diagnosis and confirmed by the MINI (Version 7.0.2)
- •(ii) age 18 or older
- •(iii) female participants of childbearing potential must be using a reliable method of contraception and have a negative pregnancy test at the time of enrolment and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study. Male participants must not father a baby during their time in the study
- •(iv) ability to communicate in English
- •(v) capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent
- •(vi) stabilized as outpatients with a single oral AP (risperidone or olanzapine or paliperidone*) at the same dose for ≥3 months i. On a prescribed risperidone dose of between 1-6mg, or a prescribed olanzapine dose of between 5-20mg, or a prescribed paliperidone 3-12mg
- •(vii) evidence of adherence with current AP treatment
排除标准
- •(i) exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)
- •(ii) Current diagnosis of substance use disorder according to DSM-5 criteria (verified through the MINI for Psychotic Disorders (Version 7.0.2) and a positive drug screen for street and /or prescription drugs not prescribed to the participant by treating physicians
- •(iii) ECT within the last 3 months
- •(iv) pregnancy or lactation
- •(v) neurological condition (dementia including Alzheimer's disease, multiple sclerosis, epilepsy, stroke, or traumatic brain injury)
- •(vi) allergy to the study drugs and their excipients
- •(vii) allergy (e.g., galactosaemia) or severe intolerance to lactose
- •(viii) negative urine drug screen result for Olanzapine or Risperidone or Paliperidone (if applicable)
研究组 & 干预措施
Extended Dosing Group
Participants taking olanzapine or risperidone or paliperidone will be switched to an alternate day dosing schedule.
干预措施: paliperidone (Drug)
Treatment as Usual group
Participants will continue to take their olanzapine or risperidone or paliperidone following the same prescribed daily schedule.
Extended Dosing Group
Participants taking olanzapine or risperidone or paliperidone will be switched to an alternate day dosing schedule.
干预措施: Olanzapine (Drug)
Extended Dosing Group
Participants taking olanzapine or risperidone or paliperidone will be switched to an alternate day dosing schedule.
干预措施: Risperidone (Drug)
结局指标
主要结局
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
时间窗: 0 and 52 weeks
Change in the Brief Psychiatric Rating Scale - total scores from baseline to 52 weeks. The score values for each item on the BPRS range from 1 to 7. The higher the score for each item the worse the outcome. The values for each item on the BPRS are scored as follows: 1- Not Present, 2 - Very Mild, 3- Mild, 4- Moderate, 5 - Moderately Severe, 6- Severe, 7- Very Severe.
次要结局
- Exploratory Outcomes - Function 3 using the "Recovery Assessment Scale"(0 and 52 weeks)
- Exploratory Outcomes - Symptoms 1 using "The Clinical Global Impression - Schizophrenia Scale"(0 and 52 weeks)
- Exploratory Outcomes - Symptoms 3 using the "Calgary Depression Scale for Schizophrenia"(0 and 52 weeks)
- Exploratory Outcomes - Symptoms 4 using the "Yale-Brown Obsessive-Compulsive Scale"(0 and 52 weeks)
- Exploratory Outcomes - Symptoms 5 using the "Hamilton Anxiety Scale"(0 and 52 weeks)
- Exploratory Outcomes - Wellbeing 3 using the "Subject Happiness Scale"(0 and 52 weeks)
- Exploratory Outcomes - Symptoms/Side Effects using "The Clinical Global Impression - Schizophrenia Scale"(0 and 52 weeks)
- Exploratory Outcomes - Wellbeing 2 using the "Quality of Life and Satisfaction Questionnaire - Short Form"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 2 using the "Neurological Evaluation Scale"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 3 using the "Glasgow Assessment Side-Effect Scale"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 5 using the "Barnes Akathisia Rating Scale"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 6 using the "Simpson Angus Scale"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 7 using the "Abnormal Involuntary Movement Scale"(0 and 52 weeks)
- Exploratory Outcomes - Wellbeing using the "Quality of Life and Satisfaction Questionnaire"(0 and 52 weeks)
- Exploratory Outcomes - Function 1 using the "Social and Occupational Function Assessment Scale"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 1 using the "Leibowitz Social Anxiety Scale"(0 and 52 weeks)
- Exploratory Outcomes - Side Effects 4 using the "Drug Attitude Inventory" Scale(0 and 52 weeks)
- Exploratory Outcomes - Function 2 using the "Personal and Social Performance Scale"(0 and 52 weeks)
研究者
Gary Remington
Senior Scientist
Centre for Addiction and Mental Health