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A study to assess the benifits and side effects of long-acting olanzapine injection in patients with schizophrenia.

Prospective Observational study of Effectiveness and tolerability of Olanzapine Long-Acting Injection in patients with Schizophrenia - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/100088
Enrollment
50
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: NIL: NIl Control Intervention1: NIL: NIL

Sponsors

Dr. M.K. Shah Medical College and Research Centre, Ahmedabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impression Severity (CGI-S) score from baseline during follow-up. For safety, Simpson-Agnus score (SAS), Barnes akathisia scale (BAS), Abnormal involuntary movement scale (AIMS), Richmond agitation sedation scale (RASS).Timepoint: At baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks and 48 weeks.—

Secondary

MeasureTime frame
1. Change in Clinical Global Impression Improvement (CGI-I) score from baseline during follow-up. 2. Occurrence & severity of extrapyramidal symptoms assessed using Simpson Angus Scale (SAS). 3. Occurrence & severity of akathisia assessed using Barnes Akathisia Scale (BAS). 4. Occurrence & severity of abnormal involuntary movements assessed using Abnormal Involuntary Movement Scale (AIMS). 5. Level of sedation & agitation assessed using Richmond Agitation Sedation Scale (RASS). Timepoint: At baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks,44 weeks & 48 weeks.—

Countries

India

Contacts

Public ContactDr Hitarth N Patel

Dr. M.K. Shah Medical College and Research Centre and SMS Multispecialty Hospital, Ahmedabad

dr.vk1987@gmail.com9228249767

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026