FindTrial
Sign In

To compare efficacy and side effects of addition of Amisulpride versus Blonanserin to Clozapine in Treatment Resistant Schizophrenia

Comparative effectiveness and tolerability of Amisulpride versus Blonanserin augmentation to Clozapine in Treatment Resistant Schizophrenia - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068971
Enrollment
68
Registered
2024-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Amisulpride: Antipsychotic drug Amisulpride will be started on 50 mg per day and uptitrated on the basis of tolerability and clinical improvement with a maximum dose of 800mg/ day. Maxi

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients having the diagnosis of Schizophrenia as per ICD 11 2.Age 18-65 years of any gender 3.Had received at least two antipsychotics agents with different mechanisms of action at appropriate doses for an adequate period of at least 6 weeks. 4.On a static therapeutic dose of Clozapine for the last 12 weeks (250-550 mg per day) 5.PANSS score more than 58

Exclusion criteria

Exclusion criteria: 1.Patients with neurological disorders like head injury, tumours, dementia, organic brain syndrome (e.g., delirium, amnesia), epilepsy. 2.Patients with comorbid substance dependence (except nicotine and caffeine). 3.Patients who are lactating or pregnant. 4.Patients with intellectual disability. 5.Actively suicidal patients. 6.Patience with any acute unstable medical or surgical illnesses. 7.History of treatment with amisulpride or blonanserin in the past. 8.History of hypersensitivity to amisulpride or blonanserin in the past.

Design outcomes

Primary

MeasureTime frame
To assess and compare the effects of amisulpride versus blonanserin augmentation to clozapine on positive and negative symptoms of treatment resistant schizophrenia using PANSS scale.Timepoint: To assess and compare the effects of amisulpride versus blonanserin augmentation to clozapine on positive and negative symptoms of treatment resistant schizophrenia at baseline, 2,4,7 and 10th week of the study—

Secondary

MeasureTime frame
Effect of treatment on quality of life, current functioning & neuropsychological assessments as measured on CDSS, WHOQOL BREF, GASS, SOFS, CGI, ASEX, MOCA, blood & other related investigations.Timepoint: 0, 2, 4, 7, 10 weeks—

Countries

India

Contacts

Public ContactDr Ajeet Sidana

Government Medical College and Hospital, Sector 32, Chandigarh

ajeetsidana@hotmail.com9056422679

Outcome results

None listed

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