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Clinical Trials/CTRI/2022/01/039860
CTRI/2022/01/039860
Not yet recruiting
Phase 4

A Multicenter, Prospective, Post Marketing Surveillance study ofAripiprazole tablet in Adolescent patients with Schizophrenia

Torrent Pharmaceuticals Limited0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: F209- Schizophrenia, unspecified

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: F209- Schizophrenia, unspecified
Sponsor
Torrent Pharmaceuticals Limited
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Pms

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female adolescent patients aged 13 to 17 years (both inclusive)
  • •2\. Patients diagnosed with schizophrenia according to the International Classification of Diseases (ICD) and who as per investigator discretion need aripiprazole therapy

Exclusion Criteria

  • •1\. Patients with known hypersensitivity to aripiprazole.
  • •2\. Patients with concurrent psychiatric comorbidity requiring pharmacotherapy and/or
  • •medications.
  • •3\. Any evidence of suicide risk; or a history or current diagnosis of schizoaffective disorder,
  • •mental retardation, major depressive episodes, neuroleptic malignant syndrome, any
  • •neurologic disorder other than Tourettes syndrome, severe head trauma, or any unstable
  • •medical condition
  • •4\. Pregnant or lactating and sexually active adolescent boys or adolescent girls who do not
  • •agree to abstinence or birth control
  • •5\. In the opinion of the investigator patient is either unable to cooperate or unlikely to

Outcomes

Primary Outcomes

Not specified

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