Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Schizophrenia Clinical Trial

Official title:

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409823
• Other study ID #: 1209-Re03-Reg
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: October 19, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Pontifical Catholic University of Argentina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Observational

Clinical Trial Summary

Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been found to be effective and safe for the treatment of schizophrenia, bipolar disorders, depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among others. Quetiapine extended-release has the same clinical efficacy as the immediate-release formulation, but reduces the amount of daily doses, possibly contributing to increased treatment adherence.

The purpose of this registry is to explore adherence to treatment, the occurrence of adverse drug reactions and the clinical outcomes in a sample of patients under treatment with atypical antipsychotics in several Central American countries. For this study, clinical data will be extracted from the medical records of 1000 patients with schizophrenia, depressive disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions, namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic hypotension; adherence to treatment; and changes in quality of life and clinical status will be assessed during the first 8 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years-old

• have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination

• such patients should receive antipsychotics as their usual treatment

• they should give informed consent before participating

Exclusion Criteria:

• no treatment with atypical antypsichotics

• other diseases

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bipolar Depressive Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Hallucinations
• Major Depressive Disorder
• Parkinson Disease
• Parkinson's Disease With Hallucinations
• Schizophrenia

Intervention

Drug:
• Atypical Antipsychotics
any atypical antipsychotic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontifical Catholic University of Argentina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Drug Reactions		8 weeks	Yes
Primary	Adherence to treatment		8 weeks	No
Secondary	Quality of Life		8 weeks	No
Secondary	Clinical status (CGI score)		8 weeks	No