Bipolarlife e-Library RANZCP Treatment Guidelines for Bipolar Disorder

RANZCP Treatment Guidelines for Bipolar Disorder

12–14 September 2003, Bipolar Disorder Scientific Meeting – Christchurch, New Zealand
Professor Philip Mitchell
Professor and Head of the School of Psychiatry, University of New South Wales, Australia

During 2003, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) has developed Australasian guidelines for the treatment of bipolar disorderunder contract from Australia’s Commonwealth Department of Health and Ageing.
In accordance with National Health and Medical Research Council recommendations for guideline development, the Steering and Implementation Committee undertook a comprehensive literature review of publications up to June 2003, including previous guidelines developed in Australia and elsewhere and consulted with clinical experts and consumers. The resulting guidelines are intended to assist, but not dictate, clinical decisions. A version for consumers has been published on the RANZCP website (www.ranzcp.org).

Recommendations are set out according to phase of illness and include guidance on assessment as well as treatment. In the absence of randomised controlled clinical trials (RCTs) conducted specifically in patients with bipolar II disorder, the guidelines are based on clinical literature on bipolar I disorder.

Managing hypomania or mania

The structure of the guidelines reflects the recognition that the care of a person during a manic episode involves both an immediate response to the psychiatric emergency and later comprehensive assessment.
Treatment for hypomania or mania is based on a mood stabiliser, plus adjunctive treatments for specific symptoms. There is substantial evidence for the use of mood stabilisers, particularly lithium. Meta-analysis of RCTs has shown that valproate and carbamazepine are as effective as lithium in the management of acute mania.There have also been two RTCs confirming the effectiveness of olanzapine for mania. In contrast, there is only limited evidence available to guide the choice of adjuncts, despite their widespread use in practice.

Mixed episodes

Compared with acute mania, there is less high-level evidence to guide the management of mixed–mood episodes. RCTs support the use of valproate.
Failure of mania/hypomania to respond to initial treatment
There have been no systematic reviews and few RCTs to guide the management of mania non-responsive to initial therapy. Forinstance, there have been no clinical trials conducted to evaluate the well-accepted practice of optimising mood stabiliser serum levels before changing the regimen. Based on expert consensus and limited clinical data, the guidelines recommend any of the following: optimise the mood stabiliser dose, switch to another mood stabiliser, combine mood stabilisers, or augment mood stabiliser therapy with olanzapine, hypomania or mania
The structure of the guidelines reflects the recognition that the care of a person during a manic episode involves both an immediate response to the psychiatric emergency and later comprehensive assessment.
Treatment for hypomania or mania is based on a mood stabiliser, plus adjunctive treatments for specific symptoms. There is substantial evidence for the use of mood stabilisers, particularly lithium. Meta-analysis of RCTs has shown that valproate and carbamazepine are as effective as lithium in the management of acute mania.There have also been two RTCs confirming the effectiveness of olanzapine for mania. In contrast, there is only limited evidence available to guide the choice of adjuncts, despite their widespread use in practice.

Failure of mania/hypomania to respond to initial treatment

There have been no systematic reviews and few RCTs to guide the management of mania non-responsive to initial therapy. Forinstance, there have been no clinical trials conducted to evaluate the well-accepted practice of optimising mood stabiliser serum levels before changing the regimen. Based on expert consensus and limited clinical data, the guidelines recommend any of the following: optimise the mood stabiliser dose, switch to another mood stabiliser, combine mood stabilisers, or augment mood stabiliser therapy with olanzapine, risperidone or haloperidol.
In the event of continued failure to respond, the guidelines recommend reevaluation of the diagnosis, considering other psychoses or organic disorders. If the diagnosis is upheld, the use of electroconvulsive therapy (ECT) is supported by RCTs.

Maintenance therapy following a manic/ hypomanic episode

Although clinical consensus supports maintenance therapy protocols, there is no RCT evidence in this area. Based on systematically evaluated expert consensus, the guidelines recommend at least 6months’ maintenance treatment after the first manic episode. Forpatients with established long-term bipolar disorder who have recovered from a manic episode, various criteria for continuing therapyare supported by expert consensus.

Managing bipolar depression

As for mania, recommendations for the care of patients during a bipolar depressive episode are set out in order of initial assessment and management, followed by comprehensive clinical assessment.
In patients with a diagnosis of bipolar disorder who experience a denovo
depressed episode in the absence of mood stabiliser therapy, a large volume of good-quality evidence supports the introduction of a mood stabiliser. The guidelines recommend using lithium or lamotrigine, either alone or in combination with an antidepressant, as supported by expert consensus, but not RCTs. The use of SSRIs, tricyclic antidepressants and monoamine oxidase inhibitors in bipolar depression is supported by RCTs, while the use of venlafaxine is supported by uncontrolled trials. There is no evidence for the efficacy of an antidepressant in the absence of a mood stabiliser in bipolar depression.
For those who experience a breakthrough episode of bipolar depression during treatment with a single mood stabiliser, the guidelines recommend assessment and optimisation of mood stabiliser blood levels, followed by the addition of an antidepressant or second mood stabiliser if the patient has not responded. Both augmentation options are supported by RCTs.

Failure of bipolar depression to respond to initial treatment

No evidence is available from RCTs conducted specifically in patients with bipolar depression that has failed to respond to initial therapy. Based on expert consensus, the guidelines recommend either switching to another antidepressant, switching to another mood stabiliser, or ECT. In the case of persistent failure to respond, the guidelines recommend confirmation of the diagnosis, re-evaluation of contributing psychological or social factors and consideration of adjunctive psychological therapies.
The guidelines recommend withdrawing antidepressants 2–3 months after an episode of bipolar depression in order to minimise the risk of precipitating mania or rapid cycling.

Maintenance therapy following a depressive episode

The guidelines also acknowledge that maintenance antidepressant treatment may be appropriate in patients with recurrent depressive episodes, if administered in conjunction with a mood stabiliser and after balancing the patient’s treatment requirement with the risk of precipitating mania or rapid cycling. These practices are supported by expert consensus, but have not been evaluated in RCTs.

Prophylactic therapy in bipolar disorder

Various criteria have been proposed for long-term prophylaxis in bipolar disorder.For patients with non-rapid cycling bipolar disorder, the guidelines recommend maintenance therapy with either lithium, lamotrigine, valproate or carbamazepine. The use of lithium at a serum target range of 0.6–0.8 mmol/L is supported by systematic reviews, which demonstrate that the ‘number needed to treat’ to prevent a mood episode is between 4 and 14.
There is very limited evidence to guide the choice of prophylactic treatment in patients with rapid-cycling bipolar disorder. Based on clinical case series and expert consensus, the guidelines recommend valproate,lamotrigine, carbamazepine or lithium.

Psychological interventions

The guidelines recommend psychoeducation (individual, family-focused or group therapy), cognitive-behavioural therapy (CBT) or interpersonal and social rhythm therapy (IPSRT) as prophylactic therapy in bipolar disorder. CBT and psychoeducation modalities for patients with bipolar disorder are well supported by RCTs. Since completion of the guidelines, new reported data indicate that IPSRT is not significantly more effective than standard care in patients with bipolar disorder. For all psychotherapies, the main therapeutic effect observed in bipolar disorder is the prevention of depressive episodes.

Failure to respond to prophylaxis

In the case of failure to respond to prophylaxis, the guidelines advise assessment of adherence to treatment and management of comorbid substance misuse before changing the drug regimen. In patients with rapid-cycling bipolar disorder, the possibilities of antidepressant-induced affective instability and subclinical hypothyroidism should also be considered and excluded.
1For patients who do not benefit from prophylactic therapy for bipolar disorder, there is some evidence that adding a second mood stabiliser (particularly using the combination of lithium and valproate) enhances prophylactic capacity.

References

1. Mitchell P, Malhi G, Redwood B, Ball J for the RANZCP Clinical Practice Guideline Team for Bipolar Disorder. RANZCP
clinical practice guidelines. Summary of guidelines for the treatment of bipolar disorder Australasian Psychiatry2003; 11 :39–53.
2. Macritchie K, Geddes JR, Scott J et al. Valproate for acute mood episodes in bipolar disorder (Cochrane Review). In:TheCochrane Library, Issue 3, 2003. Oxford: Update Software.
3. Hirschfeld RMA, Bowden CL, Gitlin MJ et al. Practice guideline for the treatment of patients with bipolar disorder (Revision). Am J Psychiat2002; 4 (Suppl.): 1–50.
4. Mood Disorders: Pharmacologic Prevention of Recurrences. NIH Consensus Statement Online 1984 Apr 4–26 [cited1October 2003]; 5: 1–23.
5. Grof P, Angst J, Karasek M, Keitner G. Patient selection for long-term lithium treatment in clinical practice. ArchGenPsychiatry 1979; 39 (8 Spec No): 894–7.
6. Goodwin FK, Jamison KR. Manic Depressive Illness. New York: Oxford University Press, 1990. 7. Calabrese JR, Delucchi GA.: Spectrum of efficacy of valproate in 55 patients with rapid-cycling bipolar disorder.
AmJPsychiatry 1990, 147 : 431–4.

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