Prospective Observational study of Effectiveness and tolerability of Olanzapine Long-Acting Injection in patients with Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This is a prospective observational study, and the study aims to evaluate the safety and efficacy of olanzapine long-acting injection in treatment nonadherent patients with schizophrenia. . The diagnosis and the drug to be prescribed will be decided by the consultant psychiatrist. Patients who are prescribed olanzapine long-acting injection by a consultant psychiatrist will be included in the study. A total of 50 patients who meet the inclusion criteria and who will provide written informed consent will be recruited for the study. LAI of olanzapine is administered in the upper and outer quadrant of the gluteal muscle using the Z-track technique, and after that, patients will be kept under observation for 3 hours for post-injection delirium and sedation syndrome. Assessment of participants will be done at every follow up by trained resident doctor of psychiatry department during each follow-up using semi structured proforma, it includes demographic details, positive and negative syndrome scale (PANSS) and Clinical global impression on severity and improvement (CGI) for efficacy, simpson-agnus score (SAS), Barnes akathisia scale (BAS), Abnormal involuntary movement scale (AIMS), Richmond agitation sedation scale (RASS) for safety. Assessment of laboratory investigation reports will be done at screening period and then every three months till 12 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18-60 years.
- •Patients with schizophrenia disorder and prescribed olanzapine long-acting injection.
- •DSM-5TR Patients with poor/non-compliance towards oral anti-psychotic drugs.
- •The patient and/or their primary caregiver is willing to provide written informed consent.
排除标准
- •Age below 18 years and above 60 years.
- •Non-consent for participation in the study.
- •Patients who are not prescribed olanzapine LAI.
- •History of one or more seizures without a clear and resolved aetiology.
- •Significant suicidal or homicidal risk.
- •Pregnant or lactating women.
- •Acute, serious, or unstable medical conditions.
- •Substance (except nicotine and caffeine) dependence within the past 30 days.
研究者
Dr Hitarth N Patel
Dr. M.K. Shah Medical College and Research Centre and SMS Multispecialty Hospital, Ahmedabad
