Severe Mood DysregulationNCT00825552
Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation
A study testing Risperidone in people with Severe Mood Dysregulation, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
Trial summary
The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Severe Mood Dysregulation
- What is being tested?
- Risperidone
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2009to Nov 2010
- Phase
- Interventional
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnose of Severe Mood Dysregulation
- 7-17 years
- IQ > 70
Who cannot join
- Bipolar disorder
- IQ<70
- Psychosis
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90000-010
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90350-903
About this study
Official title: Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.
The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.
Read the detailed description
Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity.
This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD.
We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.
- Conditions
- Severe Mood Dysregulation
- Being tested
- Risperidone
- Keywords
- Risperidone, Severe mood dysregulation, bipolar, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
0,5-4 mg/day for 8 weeks (twice a day)
What is being measured
The primary outcome is the main question the study is designed to answer.
We use as the primary outcome the subscale of irritability of the Aberrant Checklist Behavior which measures the intensity of irritability, temper tantruns and hyperarousal symptoms
Measured: 11/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mood DysregulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Investigators
- Rohde A Luis, Phd, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825552
- Sponsor's protocol ID
- 19091979
- Status last verified
- Jan 2009
- First submitted
- 16 Jan 2009
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.
- ClinicalTrials.gov ID
- NCT00825552
- Acronym / sponsor ID
- 19091979
- Conditions
- Severe Mood Dysregulation
- Keywords
- Risperidone, Severe mood dysregulation, bipolar, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 21 Jan 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.
The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.
Detailed description
Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity.
This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD.
We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnose of Severe Mood Dysregulation
- 7-17 years
- IQ > 70
Key exclusion criteria (3 listed)
- Bipolar disorder
- IQ<70
- Psychosis
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 |
|---|---|---|
| Risperidone0,5-4 mg/day for 8 weeks (twice a day) | Drug | – |
Primary outcome
We use as the primary outcome the subscale of irritability of the Aberrant Checklist Behavior which measures the intensity of irritability, temper tantruns and hyperarousal symptoms
Time frame: 11/2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
- Program of Bipolar Children and adolescentsLink provided by the sponsor.
Related trials for Severe Mood Dysregulation
RecruitingObservational study
Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
Mood Disorder
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.
Rohde A Luis, Phd study chair
Federal University of Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone in people with Severe Mood Dysregulation, run by Federal University of Rio Grande do Sul at 2 sites 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 3 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 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
We use as the primary outcome the subscale of irritability of the Aberrant Checklist Behavior which measures the intensity of irritability, temper tantruns and hyperarousal symptoms (time frame: 11/2010). 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 21 Jan 2009.