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A study to find out the efficacy of long-acting paliperidone in improving symptoms and well-being of people with schizophrenia or bipolar disorder.

Effectiveness and Safety of Long-Acting Injectable Paliperidone in Schizophrenia Spectrum and Bipolar Mania: A Prospective Observational Study - Not Applicable

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097443
Enrollment
60
Registered
2025-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: F200- Paranoid schizophrenia

Interventions

Intervention1: Long acting injectable paliperidone: Long-acting injectable paliperidone Details: Administered as intramuscular deep injection, dose 100 mg or 150 mg once monthly, continued for a tota

Sponsors

Government Mohan Kumaramangalam Medical College and Hospita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ICD 11 diagnosis of schizophrenia, schizoaffective disorder, or bipolar mania. Initiated on long acting injectable paliperidone for at least six weeks. Age between 18 to 65 years, any gender.

Exclusion criteria

Exclusion criteria: Diagnosis of bipolar depression or other psychotic disorders such as delusional disorder. Presence of comorbid substance use disorder except nicotine. Use of concurrent psychotropic medications.

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving at least fifty percent improvement in Clinical Global Impression Improvement (CGI I) score at twelve months.Timepoint: Outcomes will be assessed at Baseline, six months, and twelve months.

Secondary

MeasureTime frame
Assessment of metabolic & safety parameters including extrapyramidal symptoms weight BMI changes serum prolactin & glucose levels during treatment with long acting injectable paliperidoneTimepoint: At 6 months & 12 months

Countries

India

Contacts

Public ContactShankar

Government Mohan Kumaramangalam Medical College , salem

kanishkashankar2016@gmail.com9952247088

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026