NCT02409823

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
665

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

April 1, 2015

Last Update Submit

October 19, 2015

Conditions

SchizophreniaMajor Depressive DisorderBipolar Depressive DisorderParkinson's Disease With Hallucinations

Keywords

adverse drug reactionsadherence to treatmentquality of lifeclinical status

Outcome Measures

Primary Outcomes (2)

  • Occurrence of Adverse Drug Reactions

    8 weeks

  • Adherence to treatment

    8 weeks

Secondary Outcomes (2)

  • Quality of Life

    8 weeks

  • Clinical status (CGI score)

    8 weeks

Study Arms (1)

patients on atypical antipsychotics

Drug: Atypical Antipsychotics

Interventions

Atypical AntipsychoticsDRUG

any atypical antipsychotic

patients on atypical antipsychotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients under atypical antipsychotic therapy

You may qualify if:

  • 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

You may not qualify if:

  • no treatment with atypical antypsichotics
  • other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 30234617DERIVED

  • 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.

    PMID: 27021967DERIVED

MeSH Terms

Conditions

SchizophreniaDepressive Disorder, MajorDrug-Related Side Effects and Adverse ReactionsTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood DisordersChemically-Induced DisordersHealth BehaviorBehavior

Study Officials

  • Santiago Perez Lloret, MD PhD CPI

    Pontifical Catholic University of Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD CPI

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 7, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10