Bipolar DisorderPhase 4NCT00048802
Treatment and Outcome of Early Onset Bipolar Disorder
A Phase 4 study testing Lithium, Olanzapine and Divalproex in people with Bipolar Disorder, run by Northwell Health at 1 site in United States.
Trial summary
This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lithium, Olanzapine and Divalproex
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Aug 2006
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a diagnosis of Bipolar I Disorder;
- Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
- Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
- Live in the NY Metropolitan area;
- Able to attend weekly to biweekly office visits
Who cannot join
- Medical contraindication to treatment with lithium and divalproex
- Seizure disorder
- Pregnancy
- Unwillingness to use acceptable methods of birth control if sexually active
- IQ less than 70
- Substance-induced mood disorder or mood disorder due to a general medical condition
Show all 9Show fewer
- Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
- Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
- High risk for running away or truancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital, Long Island Jewish Medical Center
Glen Oaks, New York, 11004
About this study
This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
Read the detailed description
In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.
Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.
- Conditions
- Bipolar Disorder
- Being tested
- Lithium, Olanzapine, Divalproex, Risperidone, Quetiapine
- Keywords
- Adolescence
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
OlanzapineDrug
DivalproexDrug
RisperidoneDrug
QuetiapineDrug
ZiprasidoneDrug
AripriprazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2002 (estimated)
- Study startAug 2002
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Northwell HealthThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048802
- Sponsor's protocol ID
- R01MH060845
- Other IDs
- R01MH060845, DSIR 84-CTM
- Status last verified
- Jan 2014
- First submitted
- 8 Nov 2002
- Last updated
- 22 Jan 2014
- Results posted
- No
Publications
Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Adjunctive antipsychotic treatment of adolescents with bipolar psychosis. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1448-56. doi: 10.1097/00004583-200112000-00016.
PubMed 11765291Kafantaris V. Treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1995 Jun;34(6):732-41. doi: 10.1097/00004583-199506000-00013.
PubMed 7608046Kafantaris V, Coletti D, Dicker R, Padula G, Kane JM. Lithium treatment of acute mania in adolescents: a large open trial. J Am Acad Child Adolesc Psychiatry. 2003 Sep;42(9):1038-45. doi: 10.1097/01.CHI.0000070247.24125.24.
PubMed 12960703
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Outcome of Early Onset Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00048802
- Acronym / sponsor ID
- R01MH060845
- Conditions
- Bipolar Disorder
- Keywords
- Adolescence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Nov 2002 (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 study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
Detailed description
In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.
Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Have a diagnosis of Bipolar I Disorder;
- Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
- Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
- Live in the NY Metropolitan area;
- Able to attend weekly to biweekly office visits
Key exclusion criteria (9 listed)
- Medical contraindication to treatment with lithium and divalproex
- Seizure disorder
- Pregnancy
- Unwillingness to use acceptable methods of birth control if sexually active
- IQ less than 70
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 |
|---|---|---|
| Lithium | Drug | – |
| Olanzapine | Drug | – |
| Divalproex | Drug | – |
| Risperidone | Drug | – |
| Quetiapine | Drug | – |
| Ziprasidone | Drug | – |
| Aripriprazole | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Jan 2014.
- Background: PubMed 11765291Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Adjunctive antipsychotic treatment of adolescents with bipolar psychosis. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1448-56. doi: 10.1097/00004583-200112000-00016.
- Background: PubMed 7608046Kafantaris V. Treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1995 Jun;34(6):732-41. doi: 10.1097/00004583-199506000-00013.
- Background: PubMed 12960703Kafantaris V, Coletti D, Dicker R, Padula G, Kane JM. Lithium treatment of acute mania in adolescents: a large open trial. J Am Acad Child Adolesc Psychiatry. 2003 Sep;42(9):1038-45. doi: 10.1097/01.CHI.0000070247.24125.24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lithium, Olanzapine and Divalproex in people with Bipolar Disorder, run by Northwell Health 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 5 inclusion and 9 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 22 Jan 2014. 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.
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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00048802, which also lists 3 linked publications.
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 22 Jan 2014.