Bipolar DisorderPhase 4NCT02623504
DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder
A Phase 4 study testing Carbamazepine in people with Bipolar Disorder, run by Validus Pharmaceuticals at 4 sites in United States.
Trial summary
A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute manic or mixed Bipolar I Disorder Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Oct 2016to 1 Nov 2018
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written, signed and dated informed consent from subject, parents or legal guardians.
- Subject must be willing to participate for the duration of the study (8-10 months)
- Subject must meet DSM-V criteria for a primary diagnosis of bipolar I disorder.
- MINI KID administered and ruled out other psychiatric diagnosis.
- ADHD Rating Scale-IV is ruled negative.
- YMRS Score 20 or greater
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- CGI-S score of 4 or greater
- CGI-I Global Evaluation score of 4 or less
- Must be aged between 10 and 17 years
- Male and non-pregnant, non-lactating females who agree to comply with contraceptive requirements
- Functioning at an age appropriate level intellectually as deemed by the Investigator
- Subject has no co-morbid conditions that would affect efficacy, safety or tolerability or in any way interfere with the subject's participation in the study
- Subject, parents and legal guardians are able to and willing to comply with study procedures and restrictions
- Must have a satisfactory medical assessment with no clinically significant abnormalities
- Able to avoid grapefruit and grapefruit juice for the duration of the study
Who cannot join
- Subject has a current controlled or uncontrolled co-morbid psychiatric that could interfere with clinical assessments or study conduct.
- Naive subjects whose symptoms are being controlled on their prescribed medication(s) will not be eligible to participate.
- History of lack of therapeutic response to an adequate trial of carbamazepine to treat bipolar I disorder
- Believed by the Investigator to be acutely at risk for suicidal or violent behavior towards him/her or others, or a history of a suicide attempt requiring general medical intervention
- Subject's bipolar diagnosis is believed secondary to traumatic injury or another general medical condition.
- A history or known presence of clinically significant cardiovascular, hepatic, hematological, immunological (including human immunodeficiency virus, gastro-intestinal or renal disease or any other unstable medical illness that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments
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- A history of aplastic anemia, agranulocytosis or bone marrow depression
- A history of seizure disorder, other than a single childhood febrile seizure\
- A history of severe, unstable asthma
- Currently hospitalized for the treatment of psychiatric symptoms.
- Presence of any mental disorder due to a general medical condition
- Presence of abnormal thyroid function that is not adequately treated in the opinion of the Investigator
- Use of ECT, any investigational drug, CYP450 3A4 inhibitors, antidepressants, anxiolytics, sedative hypnotics, antipsychotics, mood stabilizers, ADHD medications, or clozapine in a specified time period prior to the initiation of the study
- Use of any nutraceutical to include, but not limited to any over the counter herbal preparations e.g. Gingko Biloba, St John's Wort, Kava Kava and Ephedra.
- Positive urine drug screen
- History of alcohol or other substance abuse or dependence as defined by DSM-V (except caffeine or nicotine) within the last 6months
- Female subjects with a positive pregnancy test or who are pregnant, lactating, who are less than 6 months post partum, or who cannot be relied upon to use adequate birth control
- Subjects who have previously been enrolled in the Phase IV Multi-Center , Open-Label Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Acute Manic or Mixed Bipolar I Disorder and subsequently withdrawn
- Subjects with a body weight of ≤65kg
- Family of investigational site staff
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
APG Research, LLC
Orlando, Florida, 32803
PsychCare Consultants
St Louis, Missouri, 63128
About this study
Official title: A Double Blind Study To Evaluate the Dose Tolerance and Safety of Equetro (Carbamazepine) Versus Placebo Followed by a Long-Term Maintenance in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder
A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute manic or mixed Bipolar I Disorder
Read the detailed description
The primary objective of this study is to evaluate under double blind conditions the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and adolescents aged 10-17 year diagnosed with acute manic or mixed bipolar I disorder. The safety evaluations will be based on the occurrence of treatment-emergent adverse events, laboratory values, physical examination, vital signs ECG and trough serum level of study medication. The secondary objective is to evaluate under double blind conditions the efficacy of extended release Equetro versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and Adolescents Aged 10-17 years diagnosed with acute manic or mixed Bipolar I disorder. Efficacy evaluations will be based on the measures of YMRS, CGI-S, CGI-I, CDRS-R. Manic episodes over double blind and open label periods will comprise the use of study medication and duration of night time sleep as monitored using a daily diary. Subject's will be enrolled in the double blind period for two months and evaluated on a weekly basis. Once completing the db phase they will continue on Equetro for long term maintenance for an additional six months. Placebo subject will have the opportunity to continue for another eight months in the study. The first two months will be the titration period as was done in the db phase and then they will have the option to continue in the study for an open long term maintenance for and additional 6 months. During the maintenance period subjects will be evaluated for safety and efficacy on a monthly basis. At the end of the study there will be a 30 day follow-up.
- Conditions
- Bipolar Disorder
- Being tested
- Carbamazepine, Placebo
- Keywords
- Carbamazepine, Equetro, Bipolar I Disorder, Bipolar I Disorder in Children
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Also called Equetro
200-1200 mg by mouth daily given in divided doses in the morning and the evening. Doses are titrated weekly in 200 mg increments based upon subject's response.
PlaceboDrug
Dosage to match active treatment by mouth twice daily in the morning and in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Equetro | Experimental | 200-1200 mg of Equetro (carbamazepine) by mouth given in divided doses in the morning and in the evening. Dosage is titrated in 200 mg increments weekly as needed according to subject response. Receives: Drug: Carbamazepine |
| Placebo | Placebo comparator | Placebo dosage to match the active Equetro treatment given in 2 daily doses in the morning and in the evening. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose tolerance and safety of Equetro based on occurrence of adverse events, lab values, physical exams, vital signs, ECG's, and trough serum levels of study medications
Measured: Duration of the study (8-10 months)
Secondary outcomes (6)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Young Mania Rating Score (YMRS)
Measured: Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using Clinical Global Impressions - Improvement and Severity (CGI-I, CGI-S)
Measured: Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Children's Depression Rating Scale - Revised (CDRS-R)
Measured: Weekly during the double blind period, monthly during the maintenance period
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's manic episodes throughout the study period
Measured: Duration of the study (8-10 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's weekly use of study medication
Measured: Weekly for the duration of the study (8-10 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the duration of subject's nighttime sleep monitored using a diary or e-diary
Measured: Weekly for the duration of the study (8-10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start24 Oct 2016
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: No apparent therapeutic effects that was superior to placebo
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Validus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Findling, MD, Study director, John Hopkins - Kennedy Krieger ResearchLawrence Ginsberg, MD, Principal investigator, Red Oak PsychiatryMorteza Nadjafi, MD, Principal investigator, APG ResearchMohd Azfar Malik, MD, Principal investigator, Psych Care Consultants Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623504
- Sponsor's protocol ID
- VAL-EQP-001
- Status last verified
- Mar 2023
- First submitted
- 24 Nov 2015
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Study To Evaluate the Dose Tolerance and Safety of Equetro (Carbamazepine) Versus Placebo Followed by a Long-Term Maintenance in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT02623504
- Acronym / sponsor ID
- VAL-EQP-001
- Conditions
- Bipolar Disorder
- Keywords
- Carbamazepine, Equetro, Bipolar I Disorder, Bipolar I Disorder in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No apparent therapeutic effects that was superior to placebo
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Validus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 7 Dec 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.
A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute manic or mixed Bipolar I Disorder
Detailed description
The primary objective of this study is to evaluate under double blind conditions the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and adolescents aged 10-17 year diagnosed with acute manic or mixed bipolar I disorder. The safety evaluations will be based on the occurrence of treatment-emergent adverse events, laboratory values, physical examination, vital signs ECG and trough serum level of study medication. The secondary objective is to evaluate under double blind conditions the efficacy of extended release Equetro versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and Adolescents Aged 10-17 years diagnosed with acute manic or mixed Bipolar I disorder. Efficacy evaluations will be based on the measures of YMRS, CGI-S, CGI-I, CDRS-R. Manic episodes over double blind and open label periods will comprise the use of study medication and duration of night time sleep as monitored using a daily diary. Subject's will be enrolled in the double blind period for two months and evaluated on a weekly basis. Once completing the db phase they will continue on Equetro for long term maintenance for an additional six months. Placebo subject will have the opportunity to continue for another eight months in the study. The first two months will be the titration period as was done in the db phase and then they will have the option to continue in the study for an open long term maintenance for and additional 6 months. During the maintenance period subjects will be evaluated for safety and efficacy on a monthly basis. At the end of the study there will be a 30 day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equetro | Experimental | Drug: Carbamazepine200-1200 mg of Equetro (carbamazepine) by mouth given in divided doses in the morning and in the evening. Dosage is titrated in 200 mg increments weekly as needed according to subject response. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo dosage to match the active Equetro treatment given in 2 daily doses in the morning and in the evening. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Written, signed and dated informed consent from subject, parents or legal guardians.
- Subject must be willing to participate for the duration of the study (8-10 months)
- Subject must meet DSM-V criteria for a primary diagnosis of bipolar I disorder.
- MINI KID administered and ruled out other psychiatric diagnosis.
- ADHD Rating Scale-IV is ruled negative.
Key exclusion criteria (20 listed)
- Subject has a current controlled or uncontrolled co-morbid psychiatric that could interfere with clinical assessments or study conduct.
- Naive subjects whose symptoms are being controlled on their prescribed medication(s) will not be eligible to participate.
- History of lack of therapeutic response to an adequate trial of carbamazepine to treat bipolar I disorder
- Believed by the Investigator to be acutely at risk for suicidal or violent behavior towards him/her or others, or a history of a suicide attempt requiring general medical intervention
- Subject's bipolar diagnosis is believed secondary to traumatic injury or another general medical condition.
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 |
|---|---|---|
| CarbamazepineAlso: Equetro200-1200 mg by mouth daily given in divided doses in the morning and the evening. Doses are titrated weekly in 200 mg increments based upon subject's response. | Drug | Equetro |
| PlaceboDosage to match active treatment by mouth twice daily in the morning and in the evening. | Drug | Placebo |
Primary outcome
Dose tolerance and safety of Equetro based on occurrence of adverse events, lab values, physical exams, vital signs, ECG's, and trough serum levels of study medications
Time frame: Duration of the study (8-10 months)
6 secondary outcomes
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Young Mania Rating Score (YMRS)
Time frame: Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using Clinical Global Impressions - Improvement and Severity (CGI-I, CGI-S)
Time frame: Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Children's Depression Rating Scale - Revised (CDRS-R)
Time frame: Weekly during the double blind period, monthly during the maintenance period
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's manic episodes throughout the study period
Time frame: Duration of the study (8-10 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's weekly use of study medication
Time frame: Weekly for the duration of the study (8-10 months)
Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the duration of subject's nighttime sleep monitored using a diary or e-diary
Time frame: Weekly for the duration of the study (8-10 months)
Results and safety
The study was stopped early (reason given: No apparent therapeutic effects that was superior to placebo). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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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.
Robert Findling, MD study director
John Hopkins - Kennedy Krieger Research
Lawrence Ginsberg, MD principal investigator
Red Oak Psychiatry
Morteza Nadjafi, MD principal investigator
APG Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbamazepine in people with Bipolar Disorder, run by Validus Pharmaceuticals at 4 sites 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 15 inclusion and 20 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 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?
The study was stopped early (reason given: No apparent therapeutic effects that was superior to placebo). 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?
Dose tolerance and safety of Equetro based on occurrence of adverse events, lab values, physical exams, vital signs, ECG's, and trough serum levels of study medications (time frame: Duration of the study (8-10 months)). 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 3 Mar 2023.