Lithium safe, effective for children with bipolar disorder

 

  • Study in young patients confirms value of short-term use; results on long-term use forthcoming

 

Baltimore, MD, USA (October 12, 2015) – A multicenter study of young patients with bipolar disorder provides what may be the most scientifically rigorous demonstration to date that lithium — a drug used successfully for decades to treat adults with the condition — can also be safe and effective for children suffering from it.

The study, led by a researcher at the Johns Hopkins Children’s Center and published Oct. 12 in Pediatrics, affirms what clinicians who prescribe this drug have observed for years and suggests that doctors can now more confidently add lithium to the armamentarium of available treatments for this vulnerable population — at least in the short term, the authors say.


Lithium is one of the oldest drugs for bipolar disorder, a chronic brain condition marked by spontaneous, seesawing bouts of abnormally high moods and depression. The drug’s ability to stabilize mood extremes has been well-established in adults. However, researchers say, although it can also be prescribed for children and teenagers, it has previously not been seriously tested in young people for safety and effectiveness.

 

Historically, they point out, children and women of childbearing age have generally been excluded from many clinical drug trials out of an abundance of caution and ethical concerns. But in recent years, research guidelines have reflected the belief that excluding such populations may in fact be harming them, because drugs are either withheld or found to behave differently than they do in other groups.

 

"Lithium is the grandfather of all treatments for bipolar disorder, but it has never been rigorously studied in children," says Robert Findling, M.D., M.B.A., a professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and director of child and adolescent psychiatry at the Johns Hopkins Children’s Center. Findling initiated the work while director of child and adolescent psychiatry at Case Western Reserve University School of Medicine.

 

Though medications used to treat schizophrenia and other psychoses are prescribed to treat bipolar disorder in children, Findling says, those drugs have been linked to substantial weight gain, a considerable medical and social drawback for young people that causes many to stop taking them.

 

Werbung

To test whether lithium is safe and as effective at treating bipolar disorder for children as it is for adults, Findling and his colleagues performed a randomized, placebo-controlled prospective study — the gold standard for clinical research — involving 81 patients seen at nine academic medical centers across the United States. The participants, split roughly equally between sexes, ranged in age from 7 to 17 and had all been diagnosed with bipolar disorder.

 

After undergoing a "washout" period for those already taking ineffective medication for this condition, 53 children started a regimen of lithium at a standard dose, then gradually increased to a maximum tolerated dose over the next eight weeks if mood symptoms weren’t controlled. The remaining 28 patients received placebo.

 

At weekly visits for the first four weeks, and then every other week for the remainder of the study period, patients’ symptoms were assessed using a survey called the Young Mania Rating Scale, along with other standard assessment tools for bipolar disorder symptoms and therapies. Patients were also questioned about side effects and given a physical exam, including a weight check.

 

Results showed that the patients on lithium experienced far more significant improvement in their symptoms over eight weeks compared with those on the placebo. Some 47 percent of those on lithium scored in the range of "very much improved" or "much improved" on the Clinical Global Impressions Scale, a rating system commonly used to assess the efficacy of treatments in patients with mental disorders, compared to 21 percent of those on the placebo.

 

Additionally, those on lithium dropped nearly six more points on average in the 60-point YMRS. Unlike antipsychotic agents, such as risperidone or olanzapine, lithium treatment was not associated with significant weight gain, and none of the patients experienced serious side effects due to the lithium treatment.

 

Findling says the findings provide a scientific and reliable confirmation of lithium’s efficacy and safety for children in the short term, offering evidence that doctors can use when deciding what medication to prescribe their pediatric patients with bipolar disorder. Further analyses are currently in progress to examine the long-term implications of lithium use, he adds. Areas of particular focus include evaluation of any potential side effects, such as weight gain, reduced kidney function or diminished thyroid function — all important considerations, as those with bipolar disorder may need a lifetime of medication and behavioral therapies.

 

Bipolar disorder affects approximately 1 percent of teens and is one of the leading causes of disability in adolescence. The disorder usually begins during adolescence or young adulthood. Bipolar disorder that starts prior to adulthood usually portends worse outcomes.

 

 

 

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, "Best Pharmaceuticals for Children Act Pediatric Off-Patent Drug Study: Lithium in the Treatment of Pediatric Mania" under contract HHSN275200503406C.

 

Relevant disclosures: Findling has consulted for drug manufacturers Bristol-Myers Squibb, Lilly, Merck, Otsuka, Pfizer, Sunovion and Validus, and has received research support from AstraZeneca, Johnson & Johnson, Bristol-Myers Squibb, Lilly, Merck, Otsuka, Pfizer, Sunovion and Validus

 


 Johns Hopkins Medicine, 12.10.2015 (tB).

MEDICAL NEWS

COVID-19 pandemic sees increased consults for alcohol-related GI and liver…
The eyes offer a window into Alzheimer’s disease
Ventilating the rectum to support respiration
Screening for ovarian cancer did not reduce deaths
Fatigue, mood disorders associated with post-COVID-19 syndrome

SCHMERZ PAINCARE

Jedes vierte Kind wünscht bessere Schmerzbehandlung
Lebensqualität von Patienten in der dauerhaften Schmerztherapie mit Opioiden verbessern
Wenn Schmerzen nach einer OP chronisch werden
Deutscher Schmerz- und Palliativtag 2021 – ONLINE: Schmerzmediziner, Politiker und…
Deutscher Schmerz- und Palliativtag 2021 – ONLINE: COVID-19-Pandemie belastet Schmerzpatienten…

DIABETES

Verbände fordern bessere Ausbildung und Honorierung von Pflegekräften für Menschen…
Minimalinvasive Geräte warnen ungenügend vor Unterzuckerung
Typ-1-Diabetes und Hashimoto-Thyreoiditis treten häufig gemeinsam auf
Risikofaktoren für einen schweren COVID-19-Verlauf bei Menschen mit Diabetes
„Wissen was bei Diabetes zählt: Gesünder unter 7 PLUS“ meldet…

ERNÄHRUNG

DGEM plädiert für Screening und frühzeitige Aufbautherapie: Stationäre COVID-19-Patienten oft…
Führt eine vegane Ernährungsweise zu einer geringeren Knochengesundheit?
Regelmässiger Koffeinkonsum verändert Hirnstrukturen
Corona-Erkrankung: Fehl- und Mangelernährung sind unterschätze Risikofaktoren
Gesundheitliche Auswirkungen des Salzkonsums bleiben unklar: Weder der Nutzen noch…

ONKOLOGIE

Krebs – eine unterschätzte finanzielle Herausforderung
Cannabidiol gegen Hirntumore
Assistierte Selbsttötung bei Krebspatienten: Regelungsbedarf und Ermessensspielraum
Leberkrebs: Bei welchen Patienten wirkt die Immuntherapie?
Konferenzbericht vom virtuellen Münchener Fachpresse-Workshop Supportive Therapie in der Onkologie

MULTIPLE SKLEROSE

Neue S2k-Leitlinie für Diagnostik und Therapie der Multiplen Sklerose
Krankheitsbezogenes Kompetenznetz Multiple Sklerose: Stellungnahme zu SARS CoV 2 Impfdaten…
Schwangere mit MS: Schadet Schubbehandlung dem Ungeborenen?
Multiple Sklerose: Ein Sprung sagt mehr, als viele Kreuzchen auf…
Multiple Sklerose: Salzkonsum reguliert Autoimmunerkrankung

PARKINSON

Gangstörungen durch Kleinhirnschädigung beim atypischen Parkinson-Syndrom
Parkinson-Agenda 2030: Die kommenden 10 Jahre sind für die therapeutische…
Gemeinsam gegen Parkinson: bessere Therapie durch multidisziplinäre Versorgung
Neuer Bewegungsratgeber unterstützt Menschen mit M. Parkinson durch Yoga
Covid-19-Prävention: besondere Vorsicht bei Patienten mit der Parkinson-Krankheit