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Study of adverse effects of newer antipsychotic drugs

STUDY OF ADVERSE EFFECTS MONITORING OF NEWER ATYPICAL ANTIPSYCHOTIC DRUGS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/08/007225
Enrollment
200
Registered
2016-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Schizophrenia

Interventions

Intervention1: Asenapine: sublingual tablet 5 or 10 mg once, twice or thrice daily for 1 year Intervention2: Iloperidone: 2 or 4 mg tablets, orally, once or twice daily for 1 year Control Intervention

Sponsors

Pramukh Swami Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2) Prescribed any one of the following atypical antipsychotic drugs (study drugs) for the treatment of schizophrenia. • newer i.e. asenapine sublingual tablets or iloperidone oral tablets • older i.e. olanzapine oral tablets or risperidone oral tablets 3) Willing to comply with study related requirements as indicated by written informed consent from patient and his/ her legally acceptable representative (considering possible loss of insight in these patients, consent will also be taken from their legally acceptable representatives).

Exclusion criteria

Exclusion criteria: 1)History/ sign-symptom suggestive of pregnancy 2)Present history of known adverse effects associated with the study drugs to be studied (as mentioned in section 1 background).

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events commonly associated with atypical antipsychotics between newer and corresponding older drugTimepoint: over 12 months period

Secondary

MeasureTime frame
Incidence of adverse events reported in published literature that with reported in the studyTimepoint: over 12 months period

Countries

India

Contacts

Public ContactDhruvika Kharadi

Department of Pharmacology, Pramukh Swami Medical College, Karamsad

dgkharadi@yahoo.co.in

Outcome results

None listed

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