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OpenTrials
Completed

NCT Number: NCT02409823

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atypical Antipsychotics

Drug

any atypical antipsychotic

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

Sponsors and collaborators

Lead sponsor

Pontifical Catholic University of Argentina

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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