Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

NCT ID: NCT02409823

Last Updated: 2015-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

665 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Schizophrenia Major Depressive Disorder Bipolar Depressive Disorder Parkinson's Disease With Hallucinations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients on atypical antipsychotics

Atypical Antipsychotics

Intervention Type DRUG

any atypical antipsychotic

Interventions

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Atypical Antipsychotics

any atypical antipsychotic

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontifical Catholic University of Argentina

OTHER

Sponsor Role lead

Responsible Party

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Santiago Perez Lloret

MD PhD CPI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Santiago Perez Lloret, MD PhD CPI

Role: PRINCIPAL_INVESTIGATOR

Pontifical Catholic University of Argentina

References

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Rey MV, Molina L, Recinos B, Paz B, Rovelo M, Rodriguez Elias FE, Calderon J, Arellano A, Perez-Lloret S; CA-APD Study Team. Movement Disorders After Exposure to Antipsychotic Drugs in Patients With Depressive Disorders. Clin Neuropharmacol. 2018 Sep/Oct;41(5):177-180. doi: 10.1097/WNF.0000000000000300.

Reference Type DERIVED
PMID: 30234617 (View on PubMed)

Molina L, Recinos B, Paz B, Rovelo M, Elias Rodriguez FE, Calderon J, Arellano A, Pomata S, Rey MV, Perez-Lloret S. Factors Related to Early Clinical Effects of Quetiapine Extended-Release: A Multinational, Prospective, Observational Study. Clin Drug Investig. 2016 Jun;36(6):491-7. doi: 10.1007/s40261-016-0395-x.

Reference Type DERIVED
PMID: 27021967 (View on PubMed)

Other Identifiers

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1209-Re03-Reg

Identifier Type: -

Identifier Source: org_study_id

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