Bipolar DisorderPhase 3NCT02456454
Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
A Phase 3 study testing Risperidone and Valproic Acid in people with Bipolar Disorder, run by Nationwide Children's Hospital.
Trial summary
Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Risperidone and Valproic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2010
- Phase
- Phase 3
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects were male or female outpatient subjects,
- 3.0 - 7 years 11 months of age
- Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
- with a score > 20 on the Young Mania Rating Scale (YMRS.
Who cannot join
- clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;
- neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:
- CBC with differential,
- electrolytes,
- BUN,
- creatinine,
Show all 14Show fewer
- hepatic transaminases,
- urinalysis,
- thyroid indices (T3, Total T4, Free T4, TSH) and
- EKG
- mania due to a general medical condition or substance-induced mania
- mental retardation (IQ <70),
- evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
- Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
About this study
Official title: Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
Read the detailed description
The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
- Conditions
- Bipolar Disorder
- Being tested
- Risperidone, Valproic Acid, Placebo
- 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 Risperdal
Liquid risperidone
Valproic AcidDrug
Also called Valproate
Liquid valproic acid
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Experimental | Risperidone, PO 0.25-2 mg/day Receives: Drug: Risperidone |
| Valproic | Experimental | Valproic Acid PO to achieve plasma levels of 85-100 Receives: Drug: Valproic Acid |
| Placebo | Placebo comparator | Liquid placebo PO matched for color and taste. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Mania Rating Scale
Young Mania Rating Scale
Measured: 6 weeks
Secondary outcomes (1)
Clinical Global Improvement Scale
Clinical Global Improvement Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJan 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Nationwide Children's 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Principal investigator, Robert Kowatch, Nationwide Children's Hospital
- Investigators
- Robert A Kowatch, MD, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456454
- Sponsor's protocol ID
- CHMC#03-12-26
- Status last verified
- Dec 2018
- First submitted
- 24 Apr 2015
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2014.0166.
PubMed 25978742
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02456454
- Acronym / sponsor ID
- CHMC#03-12-26
- Conditions
- Bipolar Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 May 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.
Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
Detailed description
The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Experimental | Drug: RisperidoneRisperidone, PO 0.25-2 mg/day |
| Valproic | Experimental | Drug: Valproic AcidValproic Acid PO to achieve plasma levels of 85-100 |
| Placebo | Placebo comparator | Drug: PlaceboLiquid placebo PO matched for color and taste. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects were male or female outpatient subjects,
- 3.0 - 7 years 11 months of age
- Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
- with a score > 20 on the Young Mania Rating Scale (YMRS.
Key exclusion criteria (14 listed)
- clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;
- neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:
- mania due to a general medical condition or substance-induced mania
- mental retardation (IQ <70),
- evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
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: RisperdalLiquid risperidone | Drug | Risperidone |
| Valproic AcidAlso: ValproateLiquid valproic acid | Drug | Valproic |
| Placebo | Drug | Placebo |
Primary outcome
Young Mania Rating Scale
Time frame: 6 weeks
Young Mania Rating Scale
1 secondary outcome
Clinical Global Improvement Scale
Time frame: 6 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 12 Dec 2018.
- Results publication: PubMed 25978742Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2014.0166.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 2
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Bipolar Disorder
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
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.
Robert A Kowatch, MD, PhD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone and Valproic Acid in people with Bipolar Disorder, run by Nationwide Children's Hospital.
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 14 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 12 Dec 2018. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Young Mania Rating Scale (time frame: 6 weeks). 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 NCT02456454, which also lists 1 linked publication.
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 12 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.