SchizophreniaNCT00330226
Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders
An observational study of Schizophrenia and Bipolar Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Dec 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with schizophrenia or bipolar disorder receiving pharmacotherapy
Who may be able to join
- Male or female patients, 18-65 years of age.
- Patients must have a diagnosis of schizophrenia or bipolar disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Patients have not been received antipsychotics or mood stabilizers within the past 4 weeks prior to the study entry.
- Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
Who cannot join
- History of taking antipsychotics or mood stabilizers within past 4 weeks.
- History of DSM-IV substance dependence.
- Mental retardation (IQ < 70)or patients who are not able to understand the informed consent.
- Definite or suspected organic mental disorders.
- Female patients who are not able to maintain contraception during this study
- Laboratory abnormalities with clinical significance
- History of epilepsy or electroconvulsive therapy within the past 3 months.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers
The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.
Read the detailed description
Schizophrenia and bipolar disorder are renowned for chronic and deteriorating course. Although atypical antipsychotics and mood stabilizers are widely used as treatment of choice for these illness based on acute efficacy and safety, long-term efficacy and safety of these agents are still open to debate. Prospective follow-up study in naturalistic condition may be a useful way of elucidating cons and pros of long-term psychopharmacotherapy.In this study, efficacy and various side effects of drugs will be measured, and the possibility of neurophysiological markers will be tested by serial measurements of electroencephalographic changes.
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- schizophrenia, bipolar disorder, atypical antipsychotics, mood stabilizers, biological markers
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psychopharmacotherapy | patients under antipsychotic or mood stabilizer treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startJan 2006
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yong Sik Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330226
- Sponsor's protocol ID
- KYS-2006-05318
- Status last verified
- Jul 2010
- First submitted
- 25 May 2006
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Angst F, Stassen HH, Clayton PJ, Angst J. Mortality of patients with mood disorders: follow-up over 34-38 years. J Affect Disord. 2002 Apr;68(2-3):167-81. doi: 10.1016/s0165-0327(01)00377-9.
PubMed 12063145Dunner DL. Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Bipolar Disord. 2005 Aug;7(4):307-25. doi: 10.1111/j.1399-5618.2005.00235.x.
PubMed 16026484Kane JM. Treatment of schizophrenia. Schizophr Bull. 1987;13(1):133-56. doi: 10.1093/schbul/13.1.133.
PubMed 2885912Melkersson K, Dahl ML. Adverse metabolic effects associated with atypical antipsychotics: literature review and clinical implications. Drugs. 2004;64(7):701-23. doi: 10.2165/00003495-200464070-00003.
PubMed 15025545McGlashan TH. Early detection and intervention in schizophrenia: research. Schizophr Bull. 1996;22(2):327-45. doi: 10.1093/schbul/22.2.327.
PubMed 8782289Swann AC. Long-term treatment in bipolar disorder. J Clin Psychiatry. 2005;66 Suppl 1:7-12.
PubMed 15693746
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers
- ClinicalTrials.gov ID
- NCT00330226
- Acronym / sponsor ID
- KYS-2006-05318
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- schizophrenia, bipolar disorder, atypical antipsychotics, mood stabilizers, biological markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2012 (estimated)
- First posted
- 26 May 2006 (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.
The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.
Detailed description
Schizophrenia and bipolar disorder are renowned for chronic and deteriorating course. Although atypical antipsychotics and mood stabilizers are widely used as treatment of choice for these illness based on acute efficacy and safety, long-term efficacy and safety of these agents are still open to debate. Prospective follow-up study in naturalistic condition may be a useful way of elucidating cons and pros of long-term psychopharmacotherapy.In this study, efficacy and various side effects of drugs will be measured, and the possibility of neurophysiological markers will be tested by serial measurements of electroencephalographic changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychopharmacotherapy | – | –patients under antipsychotic or mood stabilizer treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with schizophrenia or bipolar disorder receiving pharmacotherapy
Key inclusion criteria (4 listed)
- Male or female patients, 18-65 years of age.
- Patients must have a diagnosis of schizophrenia or bipolar disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Patients have not been received antipsychotics or mood stabilizers within the past 4 weeks prior to the study entry.
- Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
Key exclusion criteria (7 listed)
- History of taking antipsychotics or mood stabilizers within past 4 weeks.
- History of DSM-IV substance dependence.
- Mental retardation (IQ < 70)or patients who are not able to understand the informed consent.
- Definite or suspected organic mental disorders.
- Female patients who are not able to maintain contraception during this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
- Background: PubMed 12063145Angst F, Stassen HH, Clayton PJ, Angst J. Mortality of patients with mood disorders: follow-up over 34-38 years. J Affect Disord. 2002 Apr;68(2-3):167-81. doi: 10.1016/s0165-0327(01)00377-9.
- Background: PubMed 16026484Dunner DL. Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Bipolar Disord. 2005 Aug;7(4):307-25. doi: 10.1111/j.1399-5618.2005.00235.x.
- Background: PubMed 2885912Kane JM. Treatment of schizophrenia. Schizophr Bull. 1987;13(1):133-56. doi: 10.1093/schbul/13.1.133.
- Background: PubMed 15025545Melkersson K, Dahl ML. Adverse metabolic effects associated with atypical antipsychotics: literature review and clinical implications. Drugs. 2004;64(7):701-23. doi: 10.2165/00003495-200464070-00003.
- Background: PubMed 8782289McGlashan TH. Early detection and intervention in schizophrenia: research. Schizophr Bull. 1996;22(2):327-45. doi: 10.1093/schbul/22.2.327.
- Background: PubMed 15693746Swann AC. Long-term treatment in bipolar disorder. J Clin Psychiatry. 2005;66 Suppl 1:7-12.
- Click here for the information about schizophrenia.Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Yong Sik Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Seung Chang, MD (82 31 787 7437, cjs0107@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330226, which also lists 6 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 23 Jul 2010.