Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Completed

• Conditions: Schizophrenia; Parkinson's Disease With Hallucinations; Major Depressive Disorder; Bipolar Depressive Disorder
• Interventions: Drug: Atypical Antipsychotics

• Registration Number: NCT02409823
• Lead Sponsor: Pontifical Catholic University of Argentina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 665

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients on atypical antipsychotics	Atypical Antipsychotics	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Drug Reactions	8 weeks
Adherence to treatment	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical status (CGI score)	8 weeks
Quality of Life	8 weeks