Bipolar DisorderPhase 4ProCABNCT01000402
Juvenile Bipolar Disorder Outpatient Program
A Phase 4 study testing Psychopharmacotherapy in people with Bipolar Disorder and Attention Deficit Disorder With Hyperactivity, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
This is an outpatient program for children and adolescents with bipolar disorders. The naturalistic approach of the program will allow a proper investigation of the disorder, assessment of environmental and biological factors, the conduction of treatment studies, and follow-up of the subjects. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Psychopharmacotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Nov 2014
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 6-18 years-old;
- Bipolar Disorder I, II or NOS
- Severe Mood Dysregulation
Who cannot join
- Schizophrenia
- Pervasive Developmental Disorder
- Drug use disorder
- Severe suicidal or homicidal risk, counterindicating outpatient treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90350-903
Clarissa F Paim, +55 51 21018094, cfpaim@hcpa.ufrgs.br
Silza Tramontina, D.Sc., +55 51 21018094, silza.tramontina@terra.com.br
About this study
Official title: Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
This is an outpatient program for children and adolescents with bipolar disorders. The naturalistic approach of the program will allow a proper investigation of the disorder, assessment of environmental and biological factors, the conduction of treatment studies, and follow-up of the subjects.
Read the detailed description
Inclusion criteria:
Age 6-17 years old, male and female. Bipolar Disorder I, II, and NOS (subjects presenting episodes of distinct abnormally and persistently elevated, expansive, or irritable mood, accompanied by at least three -or four if the mood is only irritable - Criteria B symptoms and present to a significant degree for at least 24 hours.
Severe Mood Dysregulation (SMD), as defined by Brotman et al. (American Journal of Psychiatry, 2007)
Exclusion criteria:
Presence of a diagnosis of Pervasive Developmental Disorder, Schizophrenia, Drug Use Disorder, and any other counter indications to outpatient treatment (significant suicide or homicide risk)
Diagnosis:
K-SADS-PL-W WASI Clinical Interview
Outcome Measures:
CBCL for general psychopathology YMRS, CMRS-P, CMRS-T for manic symptoms CDRS and CDI for depressive symptoms SNAP-IV for ADHD symptoms Scared-C and Scared-P for anxiety symptoms CGI for clinical impression, CGAS for global functioning Petersen Pubertal Scale Mood Symptom Questionnaire for SMD Screening tests for leaning disorders Family Environmental Scale, Life Events Scale, Expressed Emotion Adjective Checklist, Resilience Scale, Quality of Life for environmental and psychological factors Medication Adverse Events Checklist
- Being tested
- Psychopharmacotherapy
- Keywords
- Bipolar Disorder, Attention-Deficit/Hyperactivity Disorder, Genetics, Environmental Factors, Family Factors
- Medical subject headings
- Bipolar Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychopharmacotherapyDrug
Lithium (according to response, serum levels, and tolerance) 150-1500mg Valproate (according to response, serum levels, and tolerance) 125-2000mg Risperidone (according to response, and tolerance)0.5-6mg Olanzapine(according to response, and tolerance)2.5-20mg Ziprasidone(according to response, and tolerance)40-160mg Topiramate (according to response, and tolerance)25-300mg Quetiapine (according to response, and tolerance)25-500mg Aripiprazole (according to response, and tolerance)5-20mg Lamotrigine (according to response, and tolerance)25-200mg Fluoxetine (according to response, and tolerance) 1-40mg Sertraline (according to response, and tolerance)25-200mg Methylphenidate (according to weight, response, and tolerance)0.3 -0.7mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Psychopharmacotherapy | Other | No specific arms; Treatment decision based on available guidelines Receives: Drug: Psychopharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
Measured: Naturalistic Study - 2-year follow-up
Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder
Measured: Naturalistic 2-year follow-up
Secondary outcomes (6)
Changes in ADHD symptoms according to SNAP-IV
Measured: Naturalistic 2-year follow-up
Changes in Anxiety symptoms according to the SCARED-C and SCARED-P
Measured: Naturalistic 2-year follow-up
Changes in family functioning according to the FES-R, individual functioning according to the EEAC and Resilience Scale, environmental factors according to the Stressful Life Events Scale
Measured: Naturalistic 2-year follow-up
Presence and onset of adverse events secondary to treatment
Measured: Naturalistic 2-year follow-up
Changes in SMD symptoms according to the Mood Symptom Questionnaire
Measured: Naturalistic 2-year follow-up
Changes in general functioning according to the CGI and the CGAS
Measured: Naturalistic 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startFeb 2008
- Primary completionOct 2012 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Investigators
- Luis A Rohde, D.Sc., Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000402
- Sponsor's protocol ID
- 07-641
- Acronym
- ProCAB
- Status last verified
- Oct 2009
- First submitted
- 22 Oct 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01000402
- Acronym / sponsor ID
- ProCAB / 07-641
- Keywords
- Bipolar Disorder, Attention-Deficit/Hyperactivity Disorder, Genetics, Environmental Factors, Family Factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- Feb 2008
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 23 Oct 2009 (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.
This is an outpatient program for children and adolescents with bipolar disorders. The naturalistic approach of the program will allow a proper investigation of the disorder, assessment of environmental and biological factors, the conduction of treatment studies, and follow-up of the subjects.
Detailed description
Inclusion criteria:
Age 6-17 years old, male and female. Bipolar Disorder I, II, and NOS (subjects presenting episodes of distinct abnormally and persistently elevated, expansive, or irritable mood, accompanied by at least three -or four if the mood is only irritable - Criteria B symptoms and present to a significant degree for at least 24 hours.
Severe Mood Dysregulation (SMD), as defined by Brotman et al. (American Journal of Psychiatry, 2007)
Exclusion criteria:
Presence of a diagnosis of Pervasive Developmental Disorder, Schizophrenia, Drug Use Disorder, and any other counter indications to outpatient treatment (significant suicide or homicide risk)
Diagnosis:
K-SADS-PL-W WASI Clinical Interview
Outcome Measures:
CBCL for general psychopathology YMRS, CMRS-P, CMRS-T for manic symptoms CDRS and CDI for depressive symptoms SNAP-IV for ADHD symptoms Scared-C and Scared-P for anxiety symptoms CGI for clinical impression, CGAS for global functioning Petersen Pubertal Scale Mood Symptom Questionnaire for SMD Screening tests for leaning disorders Family Environmental Scale, Life Events Scale, Expressed Emotion Adjective Checklist, Resilience Scale, Quality of Life for environmental and psychological factors Medication Adverse Events Checklist
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychopharmacotherapy | Other | Drug: PsychopharmacotherapyNo specific arms; Treatment decision based on available guidelines |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6-18 years-old;
- Bipolar Disorder I, II or NOS
- Severe Mood Dysregulation
Key exclusion criteria (4 listed)
- Schizophrenia
- Pervasive Developmental Disorder
- Drug use disorder
- Severe suicidal or homicidal risk, counterindicating outpatient treatment
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 |
|---|---|---|
| PsychopharmacotherapyLithium (according to response, serum levels, and tolerance) 150-1500mg Valproate (according to response, serum levels, and tolerance) 125-2000mg Risperidone (according to response, and tolerance)0.5-6mg Olanzapine(according to response, and tolerance)2.5-20mg Ziprasidone(according to response, and tolerance)40-160mg Topiramate (according to response, and tolerance)25-300mg Quetiapine (according to response, and tolerance)25-500mg Aripiprazole (according to response, and tolerance)5-20mg Lamotrigine (according to response, and tolerance)25-200mg Fluoxetine (according to response, and tolerance) 1-40mg Sertraline (according to response, and tolerance)25-200mg Methylphenidate (according to weight, response, and tolerance)0.3 -0.7mg/kg/day | Drug | Psychopharmacotherapy |
Primary outcome
Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
Time frame: Naturalistic Study - 2-year follow-up
Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder
Time frame: Naturalistic 2-year follow-up
6 secondary outcomes
Changes in ADHD symptoms according to SNAP-IV
Time frame: Naturalistic 2-year follow-up
Changes in Anxiety symptoms according to the SCARED-C and SCARED-P
Time frame: Naturalistic 2-year follow-up
Changes in family functioning according to the FES-R, individual functioning according to the EEAC and Resilience Scale, environmental factors according to the Stressful Life Events Scale
Time frame: Naturalistic 2-year follow-up
Presence and onset of adverse events secondary to treatment
Time frame: Naturalistic 2-year follow-up
Changes in SMD symptoms according to the Mood Symptom Questionnaire
Time frame: Naturalistic 2-year follow-up
Changes in general functioning according to the CGI and the CGAS
Time frame: Naturalistic 2-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2009.
- Official Website of the ProCAB Outpatient ProgramLink provided by the sponsor.
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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.
Luis A Rohde, D.Sc. principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psychopharmacotherapy in people with Bipolar Disorder and Attention Deficit Disorder With Hyperactivity, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 4 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 Oct 2009. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Silza Tramontina, D.Sc. (+55 51 21018094, silza.tramontina@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI (time frame: Naturalistic Study - 2-year follow-up). 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?
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 Oct 2009.