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Quetiapine as an adjuvant for alcohol withdrawal delirium

Clinical efficacy of oral Quetiapine as an adjuvant to standard of care in patients with alcohol withdrawal state with delirium- an open-label parallel group clinical study. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069766
Enrollment
54
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: Tablet Quetiapine 25mg BD: Tb. Quetiapine will be initiated at a dose of 25 mg BD along with standard therapy- Symptom Triggered Benzodiazepine regimen till resolution of symptoms. Tab

Sponsors

Dr Jeel Vasa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18 to 60 years Patients of either gender Patients with alcohol dependance suffering alcohol withdrawal in delirium (ICD 10 criteria F10.4)

Exclusion criteria

Exclusion criteria: Ages less than 18 years, or more than 60 years. Patients with comorbid intellectual disability, history of psychosis, dementia Patients with symptoms of Wernicke’s encephalopathy showing ophthalmoplegia, ataxia on clinical examination Patients with a QTc interval above 500 msecs Patient with recent (less than 3 months) cardiac events Patients with prior allergic reactions to Quetiapine Patients with a history of extrapyramidal symptoms with use of Quetiapine. Patients with suspected multifactorial causes for the onset of delirium

Design outcomes

Primary

MeasureTime frame
Resolution of delirium tremensTimepoint: Every 6 hours scales will be applied to check if delirium has resolved

Secondary

MeasureTime frame
Length of hospital stayTimepoint: End of 10 days & every day thereafter;Number of SOS medications needed throughout admissionTimepoint: At the end of 10 days & every day thereafter

Countries

India

Contacts

Public ContactDr Jeel Vasa

All India Institute of Medical Sciences Nagpur

suyogjaiswal@aiimsnagpur.edu.in9970850212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026