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CompletedNCT02409823Updated Oct 20, 2015

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

An observational study in Schizophrenia, Major Depressive Disorder and Bipolar Depressive Disorder, sponsored by Pontifical Catholic University of Argentina. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Pontifical Catholic University of Argentina · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
665
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • adverse drug reactions
  • adherence to treatment
  • quality of life
  • clinical status
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients under atypical antipsychotic therapy

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

Exclusion Criteria:

  • no treatment with atypical antypsichotics
  • other diseases
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
665 participants (actual)
Patient registry
No

Groups and cohorts

  • patients on atypical antipsychotics

    Drug: Atypical Antipsychotics

Interventions

  • DrugAtypical Antipsychotics

    any atypical antipsychotic

05

What researchers measure

Primary outcomes

  1. Occurrence of Adverse Drug Reactions

    Time frame: 8 weeks

  2. Adherence to treatment

    Time frame: 8 weeks

Secondary outcomes

  1. Quality of Life

    Time frame: 8 weeks

  2. Clinical status (CGI score)

    Time frame: 8 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 30234617 ↗
  • 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. PubMed 27021967 ↗
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Registry details

Key details

Study ID
NCT02409823
Lead sponsor
Pontifical Catholic University of Argentina
Responsible party
Santiago Perez Lloret (MD PhD CPI, Pontifical Catholic University of Argentina) — Principal investigator
First posted
Apr 7, 2015
Start date
Feb 2015
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Oct 20, 2015

Study contacts

Santiago Perez Lloret, MD PhD CPI
principal investigator · Pontifical Catholic University of Argentina

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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