Variant GADL1 and response to lithium therapy in bipolar I disorder.

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Abstract

Lithium has been a first-line choice for maintenance treatment of bipolar disorders to prevent relapse of mania and depression, but many patients do not have a response to lithium treatment.

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Lithium plus valproate combination therapy versus monotherapy for relapse prevention in bipolar I disorder (BALANCE): a randomised open-label trial.

Andrea Cipriani, Seena Fazel, Shon Lewis (2010)

Lithium carbonate and valproate semisodium are both recommended as monotherapy for prevention of relapse in bipolar disorder, but are not individually fully effective in many patients. If combination therapy with both agents is better than monotherapy, many relapses and consequent disability could be avoided. We aimed to establish whether lithium plus valproate was better than monotherapy with either drug alone for relapse prevention in bipolar I disorder. 330 patients aged 16 years and older with bipolar I disorder from 41 sites in the UK, France, USA, and Italy were randomly allocated to open-label lithium monotherapy (plasma concentration 0.4-1.0 mmol/L, n=110), valproate monotherapy (750-1250 mg, n=110), or both agents in combination (n=110), after an active run-in of 4-8 weeks on the combination. Randomisation was by computer program, and investigators and participants were informed of treatment allocation. All outcome events were considered by the trial management team, who were masked to treatment assignment. Participants were followed up for up to 24 months. The primary outcome was initiation of new intervention for an emergent mood episode, which was compared between groups by Cox regression. Analysis was by intention to treat. This study is registered, number ISRCTN 55261332. 59 (54%) of 110 people in the combination therapy group, 65 (59%) of 110 in the lithium group, and 76 (69%) of 110 in the valproate group had a primary outcome event during follow-up. Hazard ratios for the primary outcome were 0.59 (95% CI 0.42-0.83, p=0.0023) for combination therapy versus valproate, 0.82 (0.58-1.17, p=0.27) for combination therapy versus lithium, and 0.71 (0.51-1.00, p=0.0472) for lithium versus valproate. 16 participants had serious adverse events after randomisation: seven receiving valproate monotherapy (three deaths); five lithium monotherapy (two deaths); and four combination therapy (one death). For people with bipolar I disorder, for whom long-term therapy is clinically indicated, both combination therapy with lithium plus valproate and lithium monotherapy are more likely to prevent relapse than is valproate monotherapy. This benefit seems to be irrespective of baseline severity of illness and is maintained for up to 2 years. BALANCE could neither reliably confirm nor refute a benefit of combination therapy compared with lithium monotherapy. Stanley Medical Research Institute; Sanofi-Aventis. Copyright 2010 Elsevier Ltd. All rights reserved.

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Is response to prophylactic lithium a familial trait?

Paul Grof, Anne Duffy, Patrizia A Cavazzoni … (2002)

Selecting a drug according to the treatment response in a relative has been widely accepted advice in the management of mood disorders. However, this recommendation has not been adequately substantiated in the literature. We tested the hypothesis that response to long-term lithium treatment is a familial trait. We compared response to long-term lithium treatment in bipolar relatives of bipolar lithium responders and bipolar controls. Twenty-four relatives with bipolar disorder (as determined using the Schedule for Affective Disorders and Schizophrenia-Lifetime version [SADS-L] and Research Diagnostic Criteria [RDC]) were identified in families of 106 patients with lithium-responsive bipolar disorder. A consecutive series of 40 lithium-treated patients in a bipolar clinic (meeting RDC and DSM-IV criteria for bipolar disorder) served as a comparison group. Lithium response was evaluated on a rating scale reflecting the quality and quantity of available data. The prevalence of unequivocal response among the relatives was 67%, as compared with the response rate of 35% in the comparison group (chi2 = 6.04, df = 1, p = .014). This highly significant difference in response between relatives and the control group supports the view that the response to lithium prophylaxis clusters in families.

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The European Psychiatric Association (EPA) guidance on suicide treatment and prevention.

D. Wasserman, Z Rihmer, D Rujescu … (2012)

Suicide is a major public health problem in the WHO European Region accounting for over 150,000 deaths per year. SUICIDAL CRISIS: Acute intervention should start immediately in order to keep the patient alive. An underlying psychiatric disorder is present in up to 90% of people who completed suicide. Comorbidity with depression, anxiety, substance abuse and personality disorders is high. In order to achieve successful prevention of suicidality, adequate diagnostic procedures and appropriate treatment for the underlying disorder are essential. Existing evidence supports the efficacy of pharmacological treatment and cognitive behavioural therapy (CBT) in preventing suicidal behaviour. Some other psychological treatments are promising, but the supporting evidence is currently insufficient. Studies show that antidepressant treatment decreases the risk for suicidality among depressed patients. However, the risk of suicidal behaviour in depressed patients treated with antidepressants exists during the first 10-14 days of treatment, which requires careful monitoring. Short-term supplementary medication with anxiolytics and hypnotics in the case of anxiety and insomnia is recommended. Treatment with antidepressants of children and adolescents should only be given under supervision of a specialist. Long-term treatment with lithium has been shown to be effective in preventing both suicide and attempted suicide in patients with unipolar and bipolar depression. Treatment with clozapine is effective in reducing suicidal behaviour in patients with schizophrenia. Other atypical antipsychotics are promising but more evidence is required. TREATMENT TEAM: Multidisciplinary treatment teams including psychiatrist and other professionals such as psychologist, social worker, and occupational therapist are always preferable, as integration of pharmacological, psychological and social rehabilitation is recommended especially for patients with chronic suicidality. FAMILY: The suicidal person independently of age should always be motivated to involve family in the treatment. SOCIAL SUPPORT: Psychosocial treatment and support is recommended, as the majority of suicidal patients have problems with relationships, work, school and lack functioning social networks. A secure home, public and hospital environment, without access to suicidal means is a necessary strategy in suicide prevention. Each treatment option, prescription of medication and discharge of the patient from hospital should be carefully evaluated against the involved risks. TRAINING OF PERSONNEL: Training of general practitioners (GPs) is effective in the prevention of suicide. It improves treatment of depression and anxiety, quality of the provided care and attitudes towards suicide. Continuous training including discussions about ethical and legal issues is necessary for psychiatrists and other mental health professionals. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

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Journal

Journal ID (iso-abbrev): N. Engl. J. Med.

Title: The New England journal of medicine

ISSN (Electronic): 1533-4406

ISSN (Print): 0028-4793

Publication date (Electronic): Jan 9 2014

Volume: 370

Issue: 2

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[1 ] The authors' affiliations are listed in the Appendix.

Article

DOI: 10.1056/NEJMoa1212444

PubMed ID: 24369049

SO-VID: 3d56631d-4076-474f-89d7-cd14f89c3cd5

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Variant GADL1 and response to lithium therapy in bipolar I disorder.

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Most cited references 26

Lithium plus valproate combination therapy versus monotherapy for relapse prevention in bipolar I disorder (BALANCE): a randomised open-label trial.

Is response to prophylactic lithium a familial trait?

The European Psychiatric Association (EPA) guidance on suicide treatment and prevention.

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