Table 56Summary of characteristics for anticonvulsant and antipsychotic monotherapy in long-term treatment

LamotrigineValproate semisodiumOlanzapine
No. trials (No. participants)3 RCTs (822)2 RCTs (402)1 RCT (361)
Study IDs
TOHEN2006
PopulationNorth AmericaUS; OutpatientsUS and Romania; in- and outpatients
Diagnosis
  1. Bipolar I – not in acute episode
  2. 70% Bipolar I, 30% Bipolar II; 100% rapid cycling – euthymic or in episode (any type)
  3. Bipolar I – depressed phase
  1. Bipolar I – manic phase
Bipolar I
Acute open- label phase(1) (3) 8–16 weeks, lamotrigine (>= 100mg/day) plus any other psychotropic medication required; lamotrigine titrated to achieve around 200 mg/day by beginning of randomised trial
(2) 6-week titration of lamotrigine to target dose 200 mg/day; concomitant valproate or carbamazepine allowed; between 4 and 8 weeks all meds other than lamotrigine tapered if HRSD <= 14 and MRS <= 12
  1. <= 3 months, treatment at the discretion of investigator
  2. Not applicable
6–12 weeks’ olanzapine flexible dose 5–20 mg
Patients unable to tolerate minimum dose discontinued
Study drugs
  1. Lamotrigine 100 mg–400 mg
  2. Lamotrigine 200 mg and 400 mg
  1. Valproate semisodium – serum levels 71–125 mg/l
  2. Valproate semisodium – serum levels 50–100 mg/l
Olanzapine 12.5 mg*
Concomitant medication
  1. Short-term chloral hydrate or benzodiazepine
  2. Additional pharmacotherapy for emerging mood symptoms
  3. Chloral hydrate or benzodiazepine
  1. Lorazepam and haloperidol if needed
  2. None
Anticholinergic medication where permitted
ComparatorPlaceboPlaceboPlacebo
Mean age (or range of mean ages)31–5126–39Not given
Length of trial(1) (3) 18 months
(2) 6 months
  1. 1 year
  2. 6 months*
1 year
Problems with trial(1) Not fully randomised therefore analysed separately
(3) Stopped randomising to one of the lamotrigine groups; also high-dose lamotrigine would affect cognitive function
(2) Participants recruited via the pressNone

Notes:

*

mean

From: 9, THE MEDICAL AND PHARMACOLOGICAL MANAGEMENT OF BIPOLAR DISORDER – PART II

Cover of Bipolar Disorder
Bipolar Disorder: The Management of Bipolar Disorder in Adults, Children and Adolescents, in Primary and Secondary Care.
NICE Clinical Guidelines, No. 38.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2006.
Copyright © 2006, The British Psychological Society & The Royal College of Psychiatrists.

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