Bipolar DisorderPAMSNCT00746252
Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder
A study testing risperidone and aripiprazole in people with Bipolar Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- risperidone and aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- We will include children, ages 7 - 12 years old, male and female with diagnosis of a bipolar spectrum disorder.
- Specific diagnoses included are as follows:
- Bipolar I disorder,
- Bipolar II disorder,
- Bipolar Disorder Not Otherwise Specified,
- Mood Disorder Not otherwise specified.
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- The inclusion of a spectrum of bipolar diagnosis is because children with moderate to severe impairment from mood symptoms often still do not meet criteria for Bipolar I disorder since young children tend to have more chronic (non-episodic) course of symptoms and diagnostic criteria for Bipolar I disorder are more difficult to apply to adults than young children (e.g. symptoms of grandiosity and euphoria).
- No prior treatment with an antipsychotic medication for >30 days. This criteria was added because weight loss on an assigned treatment may be due to discontinuing a prior antipsychotic medication rather than due to the current treatment.
- Recommendation from a current psychiatric treatment provider for treatment with an antipsychotic medication.
- This inclusion criteria provides an added layer of safety in that youth who have referred for the study have already been deemed by their independent provider to need an antipsychotic medication, so we are only exposing children to antipsychotic treatment who would have been treated with this type of medication regardless of whether or not there care was provided in a research or clinical program.
Who cannot join
- Medications: We will exclude children who are on current treatment with
- oral steroids,
- lithium,
- depakote since these medications will have a confounding effect on weight.
- We will allow children on stimulant medication to participate, because ADHD comorbidity is very high in prepubertal bipolar disorder (unlike adolescent or adult onset bipolar disorder).
- We are including ADHD children to thus increase generalizability of the study, and it would be inappropriate to withhold stimulant treatment from these children for a six month period.
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- Recruitment will be stratified to make sure there are equal numbers of patients on stimulants in each group.
- Somatic Conditions: We will exclude children with diabetes (type I or type II), and those with physical disability that would interfere with physical activity (will specifically exclude children whose guardian reports that the child has been medically excused from physical education at their school program because of physical disability) since insulin sensitivity and activity levels are outcome measures being assessed in this protocol.
- We will exclude youth with mental retardation, by parent report. Cognitive screening will be done with the Wechsler Abbreviated Scale of Intelligence (WASI).
- Youth with an IQ less than 70 will be excluded because they may have difficulty with self report measures.
- We will exclude children who have a history of treatment of an antipsychotic medication for >30 days, as explained above.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
Baltimore, Maryland, 21201
About this study
Official title: Investigating Metabolic Side Effects of Antipsychotic Medications in Children
The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.
Read the detailed description
This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provider as needing antipsychotic treatment of a bipolar disorder.
This study proposes to monitor changes in metabolic parameters (body mass index percentile, % body fat, insulin resistance, and lipid levels) over the course of six months treatment with aripiprazole or risperidone in youth with a bipolar spectrum disorder. We will also assess possible mechanisms of second generation antipsychotic induced weight gain by monitoring physical activity and hunger/appetite changes over the course of treatment.
- Conditions
- Bipolar Disorder
- Being tested
- risperidone, aripiprazole
- Keywords
- bipolar, children, antipsychotic, side effect
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
Also called Brand name: Risperdal
Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
aripiprazoleDrug
Also called Brand name: Abilify
children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | risperidone Receives: Drug: risperidone |
| 2 | Experimental | aripiprazole Receives: Drug: aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
Measured: These measurements are done biweekly from baseline up until 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Due low rate of participation and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Reeves, University of Maryland, Baltimore
- Investigators
- Gloria Reeves, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746252
- Sponsor's protocol ID
- HP-00043695
- Acronym
- PAMS
- Status last verified
- Jan 2020
- First submitted
- 2 Sep 2008
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Metabolic Side Effects of Antipsychotic Medications in Children
- ClinicalTrials.gov ID
- NCT00746252
- Acronym / sponsor ID
- PAMS / HP-00043695
- Conditions
- Bipolar Disorder
- Keywords
- bipolar, children, antipsychotic, side effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due low rate of participation and lack of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 21 Mar 2018
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 learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.
Detailed description
This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provider as needing antipsychotic treatment of a bipolar disorder.
This study proposes to monitor changes in metabolic parameters (body mass index percentile, % body fat, insulin resistance, and lipid levels) over the course of six months treatment with aripiprazole or risperidone in youth with a bipolar spectrum disorder. We will also assess possible mechanisms of second generation antipsychotic induced weight gain by monitoring physical activity and hunger/appetite changes over the course of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: risperidonerisperidone |
| 2 | Experimental | Drug: aripiprazolearipiprazole |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- We will include children, ages 7 - 12 years old, male and female with diagnosis of a bipolar spectrum disorder.
- Specific diagnoses included are as follows:
- The inclusion of a spectrum of bipolar diagnosis is because children with moderate to severe impairment from mood symptoms often still do not meet criteria for Bipolar I disorder since young children tend to have more chronic (non-episodic) course of symptoms and diagnostic criteria for Bipolar I disorder are more difficult to apply to adults than young children (e.g. symptoms of grandiosity and euphoria).
- No prior treatment with an antipsychotic medication for >30 days. This criteria was added because weight loss on an assigned treatment may be due to discontinuing a prior antipsychotic medication rather than due to the current treatment.
- Recommendation from a current psychiatric treatment provider for treatment with an antipsychotic medication.
Key exclusion criteria (11 listed)
- Medications: We will exclude children who are on current treatment with
- We will allow children on stimulant medication to participate, because ADHD comorbidity is very high in prepubertal bipolar disorder (unlike adolescent or adult onset bipolar disorder).
- We are including ADHD children to thus increase generalizability of the study, and it would be inappropriate to withhold stimulant treatment from these children for a six month period.
- Recruitment will be stratified to make sure there are equal numbers of patients on stimulants in each group.
- Somatic Conditions: We will exclude children with diabetes (type I or type II), and those with physical disability that would interfere with physical activity (will specifically exclude children whose guardian reports that the child has been medically excused from physical education at their school program because of physical disability) since insulin sensitivity and activity levels are outcome measures being assessed in this protocol.
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 |
|---|---|---|
| risperidoneAlso: Brand name: RisperdalChildren will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing. | Drug | 1 |
| aripiprazoleAlso: Brand name: Abilifychildren will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months. | Drug | 2 |
Primary outcome
Weight Gain
Time frame: These measurements are done biweekly from baseline up until 12 weeks
Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gloria Reeves, M.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risperidone and aripiprazole in people with Bipolar Disorder, run by University of Maryland, Baltimore at 1 site in United States.
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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Jan 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Gain (time frame: These measurements are done biweekly from baseline up until 12 weeks). 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 6 Jan 2020.