SchizophreniaNCT02409823
Clinical Registry of Patients Under Treatment With Atypical Antipsychotics
An observational study of Schizophrenia and Major Depressive Disorder, run by Pontifical Catholic University of Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Major Depressive Disorder, Bipolar Depressive Disorder
- What is being tested?
- Atypical Antipsychotics
- How many people
- 665 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients under atypical antipsychotic therapy
Who may be able to join
- 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
Who cannot join
- no treatment with atypical antypsichotics
- other diseases
About this study
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.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar Depressive Disorder, Parkinson's Disease With Hallucinations
- Being tested
- Atypical Antipsychotics
- Keywords
- adverse drug reactions, adherence to treatment, quality of life, clinical status
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atypical AntipsychoticsDrug
any atypical antipsychotic
| Study group | Role | What they receive |
|---|---|---|
| patients on atypical antipsychotics | Not described Receives: Drug: Atypical Antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Drug Reactions
Measured: 8 weeks
Adherence to treatment
Measured: 8 weeks
Secondary outcomes (2)
Quality of Life
Measured: 8 weeks
Clinical status (CGI score)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifical Catholic University of Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Perez Lloret, Pontifical Catholic University of Argentina
- Investigators
- Santiago Perez Lloret, MD PhD CPI, Principal investigator, Pontifical Catholic University of Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409823
- Sponsor's protocol ID
- 1209-Re03-Reg
- Status last verified
- Oct 2015
- First submitted
- 1 Apr 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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 30234617Molina 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry of Patients Under Treatment With Atypical Antipsychotics
- ClinicalTrials.gov ID
- NCT02409823
- Acronym / sponsor ID
- 1209-Re03-Reg
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Pontifical Catholic University of ArgentinaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients on atypical antipsychotics | – | Drug: Atypical Antipsychotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients under atypical antipsychotic therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- no treatment with atypical antypsichotics
- other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atypical Antipsychoticsany atypical antipsychotic | Drug | patients on atypical antipsychotics |
Primary outcome
Occurrence of Adverse Drug Reactions
Time frame: 8 weeks
Adherence to treatment
Time frame: 8 weeks
2 secondary outcomes
Quality of Life
Time frame: 8 weeks
Clinical status (CGI score)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Derived from this study: PubMed 30234617Rey 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.
- Derived from this study: PubMed 27021967Molina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Perez Lloret, MD PhD CPI principal investigator
Pontifical Catholic University of Argentina
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Major Depressive Disorder, run by Pontifical Catholic University of Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Drug Reactions (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.