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. 2019 Jun 1;2019(6):CD004048. doi: 10.1002/14651858.CD004048.pub4

GlaxoSmithKline 2005.

Methods Study design:
double‐blind, parallel, placebo‐controlled study
Participants Diagnosis: people who were bipolar I who were currently experiencing an acute manic or mixed episode according to DSM‐IV criteria
Method of diagnosis: score on the MRS from SADS‐C of ≥ 18. The current manic or mixed episode was to have a duration of at least 1 week, but no greater than 3 months.
Age: for lithium, median = 35.7 (SD = 13.8) years; for lamotrigine, median = 39.0 (SD = 13.1) years; for placebo, median = 38 (SD = 14.5) years; at least 18 years old
Sex: lithium 39 women; 39 men, lamotrigine 37 women; 37 men, placebo 32 women; 45 men.
Location: 38 centres in Australia (3), Austria (1), Bulgaria (4), Croatia (4), Czech Republic (4, France (3), Hungary (5), India (4), New Zealand (1), Poland (2), Russia (1), Singapore (1), South Africa (3) and UK (2)
Co‐morbidities: not described
Adjunctive therapy: none
Adjunctive medication: not described
Interventions Participants were randomly assigned to either:
Experimental arm ‐ lithium
N = 78
Duration: 42 days
Treatment protocol: lithium (dosed to therapeutic serum levels 0.7‐ 1.3 mEq/L)
Therapist/face‐to‐face contact: not described
Comparator arm ‐ lamotrigine
N = 74
Duration: 42 days
Treatment protocol: lamotrigine (weeks 1 and 2, 25 mg; weeks 3 and 4, 50 mg; week 5, 100 mg; week 6, 200 mg)
Therapist/face‐to‐face contact: not described
Comparator arm ‐ placebo
N = 77
Duration: 42 days
Treatment protocol: placebo as monotherapy
Therapist/face‐to‐face contact: not described
Outcomes Timepoints for assessment:
Primary outcome:

  1. MRS Day 42 (MRS from SAD‐C (First 11 items))


Secondary outcome:

  1. MRS from SAD‐C (Total Score 16 items)

  2. Manic Syndrome Subscale of MRS

  3. Hamilton Depression Scale (HAMD‐31 )

  4. BPRS

  5. CGI‐S

  6. GAS

  7. Participants with concomitant psychiatric medications during treatment phase

  8. Adverse events

  9. Withdrawal
Notes Date of study: 27 January 1998‐8 March 1999
Funding source: GSK
Declarations of interest among the primary researchers: not described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomised …in a randomised manner using a balanced design (i.e. 1:1:1 ratio).
Allocation concealment (selection bias) Unclear risk Not described
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias) 
 All outcomes High risk Only 50% completion
Selective reporting (reporting bias) Low risk Only end of study data reported
Other bias Low risk None identified