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Trial record 2 of 308 for:    atypical antipsychotics

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02409823
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):
Santiago Perez Lloret, Pontifical Catholic University of Argentina

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.

Condition or disease Intervention/treatment
Schizophrenia Major Depressive Disorder Bipolar Depressive Disorder Parkinson's Disease With Hallucinations Drug: Atypical Antipsychotics

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Study Type : Observational
Actual Enrollment : 665 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Registry of Patients Under Treatment With Atypical Antipsychotics
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
patients on atypical antipsychotics Drug: Atypical Antipsychotics
any atypical antipsychotic

Primary Outcome Measures :
  1. Occurrence of Adverse Drug Reactions [ Time Frame: 8 weeks ]
  2. Adherence to treatment [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 8 weeks ]
  2. Clinical status (CGI score) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • no treatment with atypical antypsichotics
  • other diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02409823

Sponsors and Collaborators
Pontifical Catholic University of Argentina
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Principal Investigator: Santiago Perez Lloret, MD PhD CPI Pontifical Catholic University of Argentina
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Santiago Perez Lloret, MD PhD CPI, Pontifical Catholic University of Argentina Identifier: NCT02409823    
Other Study ID Numbers: 1209-Re03-Reg
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Santiago Perez Lloret, Pontifical Catholic University of Argentina:
adverse drug reactions
adherence to treatment
quality of life
clinical status
Additional relevant MeSH terms:
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Antipsychotic Agents
Parkinson Disease
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs