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Bipolar I Disorder Without Psychotic SymptomsPhase 2NCT00442039

Lithium for the Treatment of Pediatric Mania

A Phase 2 study testing Lithium Carbonate in people with Bipolar I Disorder Without Psychotic Symptoms, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to examine the efficacy and safety of lithium in the treatment of pediatric patients with bipolar I disorder. Read more about this study

Who is it for?
Ages 7 to 17 years
What is being tested?
Lithium Carbonate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteUnited States
Study dates
Dec 2006to Sep 2009
Phase
Phase 2
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

  • The patient was between the ages of 7 years and 17 years, 11 months at time of first dose.
  • The patient met DSM-IV diagnostic criteria, as assessed by a semi-structured assessment (Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime [KSADS-PL]) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in Bipolar I disorder.
  • The patient had a score of ≥ 20 on the YMRS at screening and baseline.
  • The patient and legal guardian understood the nature of the study and were able to comply with protocol requirements. The legal guardian gave written informed consent and the youth, written assent.
  • Patients with comorbid conditions (attention deficit hyperactivity disorder [ADHD], conduct disorder) were eligible to participate.
  • If female: the patient was premenarchal, or was incapable of pregnancy because of a hysterectomy, tubal ligation, or spousal/partner sterility. If sexually active and capable of pregnancy, the patient must have been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least 1 month prior to study entry and agreed to continue to use one of them for the duration of the study. If sexually abstinent and capable of pregnancy, the patient agreed to continue abstinence or to use of an acceptable method of birth control (either intrauterine device or spermicide and barrier) should sexual activity commence.
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  • If female, the patient had a negative quantitative serum ß-human chorionic gonadotrophin hormone pregnancy test at screening and a negative qualitative urine pregnancy test at baseline, if female.
  • Patients with a history of substance abuse were eligible to participate if they agreed to continue to abstain from drugs during the trial and had a negative drug screen at screening or prior to baseline.
  • The patient was willing and clinically able to washout (approximately 5 half-lives) of exclusion medications during the screening period and prior to the administration of lithium. (No stable patients were asked to discontinue medications.)
  • The patient"s ECG and blood work (including complete blood count [CBC], electrolytes, etc.) showed no clinically significant abnormalities.

Who cannot join

  • The patient was clinically stable on current medication regiment for bipolar disorder.
  • The patient had a current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (Austin Screening Questionnaire score > 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder.
  • The patient had a current DSM-IV diagnosis of Substance Dependence.
  • The patient had a positive drug screen at screening and on retest 1-3 weeks later.
  • The patient had symptoms of mania that may have been attributable to a general medical condition, or secondary to use of medications (eg, corticosteroids)
  • The patient had evidence of any serious and/or unstable neurological illness for which treatment under the auspices of this study would have been contra-indicated.
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  • The patient had any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.
  • The patient had a current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might have been affected adversely by lithium, could have influenced the efficacy or safety of lithium, or would have complicated interpretation of study results.
  • The patient had evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it was appropriately safe for the patient to participate in this study.
  • The patient had evidence of current active hallucinations and delusions such that in the treating physician's opinion it was not appropriately safe for the patient to participate in this study.
  • The patient had concomitant prescription of over-the-counter medication or nutritional supplements that would interact with lithium or the patient"s physical or mental status.
  • The patient had any use of psychotropic agents other than stimulants within the preceding 2 weeks, including antipsychotics, monoamine oxidase inhibitors, antidepressants; use of stimulants within the preceding week; or fluoxetine or depot antipsychotics within the past month.
  • The patient had current psychotherapy treatments provided outside the study initiated within 4 weeks prior to screening.
  • The patient had a previous adequate trial with lithium (at least 4 weeks with lithium serum levels between 0.8-1.2 mEq/L).
  • The patient had a history of allergy to lithium.
  • The patient had psychiatric hospitalization within 1 month of screening for psychosis or serious homicidal/serious suicidal ideation.
  • Clinician"s judgment was that the patient was not likely to be able to complete the study as an outpatient due to psychiatric reasons.
  • The patient had a history of lithium intolerance.
  • Females who were currently pregnant or lactating.
  • Sexually active females who, in the investigators" opinion, were not using an adequate form of birth control.
  • Patients who were unable to swallow the study medication.
  • Patients for whom a baseline YMRS score of < 20 was anticipated.
  • Patients with an IQ < 70 (determined using the Wechsler Abbreviated Scales of Intelligence [WASI] Vocabulary and Matrix Reasons Subscales).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CASE Western Reserve University

    Cleveland, Ohio, 44126

Other trials in United States

About this study

Official title: Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long Term Safety Period, Discontinuation Phase, and Restabilization Period.

This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to examine the efficacy and safety of lithium in the treatment of pediatric patients with bipolar I disorder.

Read the detailed description

This is a multiphase, multicenter, trial that will comprehensively examine lithium in the treatment of pediatric patients with bipolar I disorder. In order to examine the treatment of bipolar disorder with lithium, this study will include four phases of treatment. The first phase, the Pharmacokinetic Phase, will include 8 weeks of Open Label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder. Patients completing the Pharmacokinetic Phase, may be eligible to continue in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment. Subsequently, patients meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those subjects who experience a mood relapse during the Discontinuation Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.

Being tested
Lithium Carbonate, Placebo
Keywords
Mania, Lithium, Bipolar, BPCA, pediatrics
Medical subject headings
Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lithium CarbonateDrug

    The starting dose of lithium was 300 mg for patients weighing < 20 kg

  • Lithium CarbonateDrug

    The dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patient"s response and tolerability. The starting dose of lithium was 900 mg and the dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patient"s response and tolerability

  • Lithium CarbonateDrug

    The starting dose of lithium was 900 mg and the lithium dose was increased by 300 mg every 3 days, (no more than twice weekly) to maximum tolerated dose based upon the patient"s response and tolerability.

  • PlaceboDrug

    During the third phase, which is the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks.

Study groups in NCT00442039
Study groupRoleWhat they receive
Lithium dosing 1ExperimentalThe starting dose of lithium was 300 mg for patients weighing < 20 kg [no patients were enrolled that weighed less than 20 kg] and 600 mg for patients weighing ≥ 20 kg.
Receives: Drug: Lithium Carbonate
Lithium dosing 2ExperimentalThe starting dose of lithium was 900 mg and the dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patient"s response and tolerability.
Receives: Drug: Lithium Carbonate
Lithium dosing 3ExperimentalThe starting dose of lithium was 900 mg and the lithium dose was increased by 300 mg every 3 days, (no more than twice weekly) to maximum tolerated dose based upon the patient"s response and tolerability.
Receives: Drug: Lithium Carbonate
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in YMRS summary score by treatment

    Measure of efficacy

    Measured: 8 weeks

  2. Mean change in YMRS parent score

    Measure of efficacy

    Measured: 8 weeks

  3. Mean change in YMRS child score

    Measure of efficacy

    Measured: 8 weeks

  4. Rate of treatment emergent adverse events

    Measured: During administration of study drug

  5. Dosing - PK

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionApr 2009
  4. Study completionSep 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442039
Sponsor's protocol ID
NICHD-2005-07-01
Other IDs
DUNS No. 07-775-8407
Status last verified
Feb 2012
First submitted
27 Feb 2007
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Findling RL, McNamara NK, Pavuluri M, Frazier JA, Rynn M, Scheffer R, Kafantaris V, Robb A, DelBello M, Kowatch RA, Rowles BM, Lingler J, Zhao J, Clemons T, Martz K, Anand R, Taylor-Zapata P. Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study. J Am Acad Child Adolesc Psychiatry. 2019 Feb;58(2):287-296.e4. doi: 10.1016/j.jaac.2018.07.901. Epub 2018 Nov 26.

    PubMed 30738555

  • Findling RL, Frazier JA, Kafantaris V, Kowatch R, McClellan J, Pavuluri M, Sikich L, Hlastala S, Hooper SR, Demeter CA, Bedoya D, Brownstein B, Taylor-Zapata P. The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation. Child Adolesc Psychiatry Ment Health. 2008 Aug 12;2(1):21. doi: 10.1186/1753-2000-2-21.

    PubMed 18700004

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lithium Carbonate in people with Bipolar I Disorder Without Psychotic Symptoms, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 23 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 28 Feb 2012. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Mean Change in YMRS summary score by treatment (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 NCT00442039, which also lists 2 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 28 Feb 2012.

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