Bipolar DisorderPhase 2/3Lithium2NCT01166425
Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.
A Phase 2/3 study testing Lithium Carbonate in people with Bipolar Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 11 sites in United States.
Trial summary
Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants with bipolar I disorder. In order to examine the treatment of bipolar disorder with lithium, this study will include four phases of treatment. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lithium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2010to Apr 2013
- Phase
- Phase 2/3
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants aged 7 years to 17 years, 11 months old at time of first dose
- Participants must meet DSM-IV diagnostic criteria, as assessed by a semi-structured assessment (KSADS-PL) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in bipolar I disorder
- Score of > 20 on the YMRS at screening and baseline
- The participant and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent
- Participants with comorbid conditions [attention deficit hyperactivity disorder (ADHD), conduct disorder], except those listed in Exclusion Criterion 2, may participate
- If female: is premenarchal, or is incapable of pregnancy because of a hysterectomy, tubal ligation, or spousal/partner sterility. If sexually active and capable of pregnancy, has been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to study entry and agrees to continue to use one of these for the duration of the study. If sexually abstinent and capable of pregnancy, agrees to continued abstinence or to use of an acceptable method of birth control should sexual activity commence
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- Has a negative quantitative serum ß-human chorionic gonadotrophin hormone pregnancy test at screening and a negative qualitative urine pregnancy test at baseline, if female
- Participants with a history of substance abuse may participate if they agree to continue to abstain from drugs during the trial and have a negative drug screen at screening or prior to baseline. Those with an initial positive drug screen during screening may have another screen done 1-3 weeks later while in screening, and a negative result will allow the participant to participate
- The participant is willing and clinically able to wash out of exclusion medications during the screening period. Prior to the administration of lithium, participants will have not used any of the following medications: antipsychotics, monoamine oxidase inhibitors, antidepressants within the preceding 2 weeks; stimulants within the preceding week; or fluoxetine or depot antipsychotics in the past month (no stable participants will be asked to discontinue medications)
- ECG and bloodwork including CBC, electrolytes, etc. (as per Safety assessment procedures listed in Table 6) showing no clinically significant abnormalities
Who cannot join
- Participant who is clinically stable on current medication regimen for bipolar disorder
- A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (ASQ score > 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder
- Current DSM-IV diagnosis of Substance Dependence
- Positive drug screen at screening and on retest 1-3 weeks later
- Participants with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids)
- Evidence of any serious, unstable neurological illness for which treatment under the auspices of this study would be contraindicated
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- 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
- Current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might be affected adversely by lithium, could influence the efficacy or safety of lithium, or would complicate interpretation of study results
- Evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study
- Evidence of current active hallucinations and delusions such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study
- Concomitant prescription of over-the-counter medication or nutritional supplements (e.g., ibuprofen, naproxen, St John's wort) that would interact with lithium or affect the participant's physical or mental status
- Concomitant psychotherapy treatments provided outside the study initiated within 4 weeks prior to screening
- Previous adequate trial with Li+ (at least 4 weeks with Li+ serum levels between 0.8-1.2 mEq/L)
- History of allergy to lithium or lithium intolerance
- Psychiatric hospitalization within 1 month of screening for psychosis or serious homicidal/serious suicidal ideation
- Clinician's judgment that participant is not likely to be able to complete the study as an outpatient due to psychiatric reasons
- Females who are currently pregnant or lactating
- Sexually active females who, in the investigators' opinion, are not using an adequate form of birth control.
- Participants who are unable to swallow the study medication
- Participants for whom a baseline YMRS score of < 20 is anticipated
- Participants with an IQ less than 70 (determined using the Wechsler Abbreviated Scales of Intelligence {WASI} Vocabulary and Matrix Reasoning Subscales)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Massachusetts Medical School
Biotech One Suite 100, 365 Plantation, Worcester, Massachusetts, 01605
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 10032
University of Cincinnati
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
University of North Carolina - Chapel Hill
Department of Psychiatry, CB 7160, Chapel Hill, North Carolina, 27599
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
Columbia University
New York, New York, 10032
University of Kansas School of Medicine
Psychiatry and Behavioral Sciences, 1010 N Kansas St, Wichita, Kansas, 67214
Seattle Childrens Hospital Research Institute
Seattle, Washington, 98101
University of Illinois at Chicago
South Chicago Heights, Illinois, 60612
Childrens National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-term Safety Period, Double-blind, Placebo-controlled Discontinuation Phase, and Open Label Restabilization Period.
Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants 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 Efficacy Phase, will include participants being randomized to either lithium or placebo for 8 weeks to determine the efficacy of lithium in the treatment of children and adolescents with bipolar I disorder. Once participants complete the Efficacy Phase, participants may be eligible to continue in the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, participants will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants 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.
Read the detailed description
The following are the objectives of this study:
- To determine if lithium is more efficacious in reducing symptoms of mania than placebo.
- To describe the short-term safety of lithium in the pediatric population relative to placebo treatment.
- To examine the effectiveness and efficacy of lithium as a maintenance treatment for children and adolescents with bipolar I disorder.
- To examine the long-term and short-term safety and tolerability of lithium in pediatric bipolar I disorder.
- To examine the effects of lithium treatment over time on specific aspects of cognitive functioning that have been reported to be adversely affected by lithium in the adult population.
- More specifically, to determine the integrity of fine-motor, attention, verbal memory, and selected executive function domains prior to treatment at baseline, at the end of week 8/early termination of the Efficacy Phase, and at the end of week 24/early termination from the Long- Term Effectiveness Phase (after 24/32 weeks of lithium treatment).
- To examine the relationship between systemic exposure to lithium and effectiveness and toxicity.
- To examine the long-term safety and tolerability of combination therapy, lithium plus other psychotropic agents, in pediatric bipolar I disorder.
- To critically assess the efficacy of lithium for prophylaxis against recurrence of mood symptoms in children and adolescents.
- In those participants who discontinue treatment with lithium and experience a mood relapse, to determine the duration of lithium treatment necessary before re-stabilization is achieved.
- To evaluate the influence of intrinsic factors [e.g. age, gender, race, renal function, height, (measured by stadiometer) and weight] on lithium exposure.
The Study population for this study: Children and adolescents 7- 17 years of age who meet DSM-IV diagnostic criteria for Bipolar I (mania, mixed mania) without psychotic symptoms as determined by a child and adolescent psychiatrist will be eligible for this study.
- Conditions
- Bipolar Disorder
- Being tested
- Lithium Carbonate, 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.
Lithium CarbonateDrug
Also called Lithium capsules
Participants weighing ≥ 30 kg who are randomized to receive active lithium will begin treatment at 300 mg TID at visit 1 (total dose 900 mg). Participants weighing < 30 kg who are randomized to receive active lithium will begin treatment at 300 mg BID the day after visit 1 (total dose 600 mg). Based on the participant's response and tolerability, the dose will be increased by 300mg three days after the baseline visit and at scheduled in-office visits to the maximum tolerated dose. One mid-week dose increase will be scheduled in addition to the weekly increases at the scheduled in-clinic visits. On day 3 (+/- 2 days), a dose increase of 300 mg may occur based on the results of a telephone call placed by the study investigator to the participant's parent/guardian. During the telephone call, the prescribing clinician will assess medication adherence, adverse events, and overall improvement since baseline.
PlaceboDrug
Also called Placebo capsules
Participants who are randomized to receive placebo during the Efficacy Phase will receive matching placebo capsules. Dosing will be titrated as described for active lithium.
| Study group | Role | What they receive |
|---|---|---|
| Lithium Carbonate | Active comparator | Participants weighing ≥ 30 kg who are randomized to receive active lithium will begin treatment at 300 mg TID (three times a day) at visit 1 (total dose 900 mg). Participants weighing < 30 kg who are randomized to receive active lithium will begin treatment at 300 mg BID (two times a day) the day after visit 1 (total dose 600 mg). Based on the participant's response and tolerability, the dose will be increased by 300mg three days after the baseline visit and at scheduled in-office visits to the maximum tolerated dose. Receives: Drug: Lithium Carbonate |
| placebo | Placebo comparator | Participants who are randomized to receive placebo during the Efficacy Phase will receive matching placebo capsules. Dosing will be titrated as described for active lithium. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
YMRS score
Significant changes in YMRS scores from baseline to the end of each study phase.
YMRS scores are questionnaires to assess pediatric mania.
Measured: >17 months
Secondary outcomes (2)
Clinical Global Impressions Scale- Severity and Improvement
Measured: >17 months
Children Depression Rating Scale-Revised
Measured: >17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Findling, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166425
- Sponsor's protocol ID
- NICHD-2005-07-2
- Acronym
- Lithium2
- Status last verified
- May 2013
- First submitted
- 19 Jul 2010
- Last updated
- 9 Oct 2013
- 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 30738555Findling RL, Robb A, McNamara NK, Pavuluri MN, Kafantaris V, Scheffer R, Frazier JA, Rynn M, DelBello M, Kowatch RA, Rowles BM, Lingler J, Martz K, Anand R, Clemons TE, Taylor-Zapata P. Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study. Pediatrics. 2015 Nov;136(5):885-94. doi: 10.1542/peds.2015-0743. Epub 2015 Oct 12.
PubMed 26459650
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-term Safety Period, Double-blind, Placebo-controlled Discontinuation Phase, and Open Label Restabilization Period.
- ClinicalTrials.gov ID
- NCT01166425
- Acronym / sponsor ID
- Lithium2 / NICHD-2005-07-2
- Conditions
- Bipolar Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Jul 2010 (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.
Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants 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 Efficacy Phase, will include participants being randomized to either lithium or placebo for 8 weeks to determine the efficacy of lithium in the treatment of children and adolescents with bipolar I disorder. Once participants complete the Efficacy Phase, participants may be eligible to continue in the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, participants will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants 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.
Detailed description
The following are the objectives of this study:
- To determine if lithium is more efficacious in reducing symptoms of mania than placebo.
- To describe the short-term safety of lithium in the pediatric population relative to placebo treatment.
- To examine the effectiveness and efficacy of lithium as a maintenance treatment for children and adolescents with bipolar I disorder.
- To examine the long-term and short-term safety and tolerability of lithium in pediatric bipolar I disorder.
- To examine the effects of lithium treatment over time on specific aspects of cognitive functioning that have been reported to be adversely affected by lithium in the adult population.
- More specifically, to determine the integrity of fine-motor, attention, verbal memory, and selected executive function domains prior to treatment at baseline, at the end of week 8/early termination of the Efficacy Phase, and at the end of week 24/early termination from the Long- Term Effectiveness Phase (after 24/32 weeks of lithium treatment).
- To examine the relationship between systemic exposure to lithium and effectiveness and toxicity.
- To examine the long-term safety and tolerability of combination therapy, lithium plus other psychotropic agents, in pediatric bipolar I disorder.
- To critically assess the efficacy of lithium for prophylaxis against recurrence of mood symptoms in children and adolescents.
- In those participants who discontinue treatment with lithium and experience a mood relapse, to determine the duration of lithium treatment necessary before re-stabilization is achieved.
- To evaluate the influence of intrinsic factors [e.g. age, gender, race, renal function, height, (measured by stadiometer) and weight] on lithium exposure.
The Study population for this study: Children and adolescents 7- 17 years of age who meet DSM-IV diagnostic criteria for Bipolar I (mania, mixed mania) without psychotic symptoms as determined by a child and adolescent psychiatrist will be eligible for this study.
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 |
|---|---|---|
| Lithium Carbonate | Active comparator | Drug: Lithium CarbonateParticipants weighing ≥ 30 kg who are randomized to receive active lithium will begin treatment at 300 mg TID (three times a day) at visit 1 (total dose 900 mg). Participants weighing < 30 kg who are randomized to receive active lithium will begin treatment at 300 mg BID (two times a day) the day after visit 1 (total dose 600 mg). Based on the participant's response and tolerability, the dose will be increased by 300mg three days after the baseline visit and at scheduled in-office visits to the maximum tolerated dose. |
| placebo | Placebo comparator | Drug: PlaceboParticipants who are randomized to receive placebo during the Efficacy Phase will receive matching placebo capsules. Dosing will be titrated as described for active lithium. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Participants aged 7 years to 17 years, 11 months old at time of first dose
- Participants must meet DSM-IV diagnostic criteria, as assessed by a semi-structured assessment (KSADS-PL) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in bipolar I disorder
- Score of > 20 on the YMRS at screening and baseline
- The participant and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent
- Participants with comorbid conditions [attention deficit hyperactivity disorder (ADHD), conduct disorder], except those listed in Exclusion Criterion 2, may participate
Key exclusion criteria (21 listed)
- Participant who is clinically stable on current medication regimen for bipolar disorder
- A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (ASQ score > 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder
- Current DSM-IV diagnosis of Substance Dependence
- Positive drug screen at screening and on retest 1-3 weeks later
- Participants with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids)
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 CarbonateAlso: Lithium capsulesParticipants weighing ≥ 30 kg who are randomized to receive active lithium will begin treatment at 300 mg TID at visit 1 (total dose 900 mg). Participants weighing < 30 kg who are randomized to receive active lithium will begin treatment at 300 mg BID the day after visit 1 (total dose 600 mg). Based on the participant's response and tolerability, the dose will be increased by 300mg three days after the baseline visit and at scheduled in-office visits to the maximum tolerated dose. One mid-week dose increase will be scheduled in addition to the weekly increases at the scheduled in-clinic visits. On day 3 (+/- 2 days), a dose increase of 300 mg may occur based on the results of a telephone call placed by the study investigator to the participant's parent/guardian. During the telephone call, the prescribing clinician will assess medication adherence, adverse events, and overall improvement since baseline. | Drug | Lithium Carbonate |
| PlaceboAlso: Placebo capsulesParticipants who are randomized to receive placebo during the Efficacy Phase will receive matching placebo capsules. Dosing will be titrated as described for active lithium. | Drug | placebo |
Primary outcome
YMRS score
Time frame: >17 months
Significant changes in YMRS scores from baseline to the end of each study phase. YMRS scores are questionnaires to assess pediatric mania.
2 secondary outcomes
Clinical Global Impressions Scale- Severity and Improvement
Time frame: >17 months
Children Depression Rating Scale-Revised
Time frame: >17 months
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 9 Oct 2013.
- Derived from this study: PubMed 30738555Findling 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.
- Derived from this study: PubMed 26459650Findling RL, Robb A, McNamara NK, Pavuluri MN, Kafantaris V, Scheffer R, Frazier JA, Rynn M, DelBello M, Kowatch RA, Rowles BM, Lingler J, Martz K, Anand R, Clemons TE, Taylor-Zapata P. Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study. Pediatrics. 2015 Nov;136(5):885-94. doi: 10.1542/peds.2015-0743. Epub 2015 Oct 12.
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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 principal investigator
University Hospitals Cleveland Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lithium Carbonate in people with Bipolar Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 11 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 10 inclusion and 21 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 combined 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.
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?
YMRS score (time frame: >17 months). 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 NCT01166425, 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 9 Oct 2013.