Clinical trial NCT02409823: Clinical Registry of Patients Under Treatment With Atypical Antipsychotics
Official title: Clinical Registry of Patients Under Treatment With Atypical Antipsychotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Major Depressive Disorder
Bipolar Depressive Disorder
Parkinson's Disease With Hallucinations
Keywords: adverse drug reactions
adherence to treatment
quality of life
clinical status
Lead sponsor: Pontifical Catholic University of Argentina
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under atypical antipsychotic therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Adverse Drug Reactions
timeFrame: 8 weeks
measure: Adherence to treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 8 weeks
measure: Clinical status (CGI score)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pontifical Catholic University of Argentina
name: Santiago Perez Lloret, MD PhD CPI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.