Efficacy, safety and tolerability of @entity837 in doses up to 50 mg in @entity308 ( XXXX ): an open-label, pilot study.

@entity1 @entity308 @entity390 @entity11266 @entity294 @entity837 @entity10
BACKGROUND: @entity837 is licensed for use at doses up to 20 mg but is used clinically at higher doses. There is limited published data at higher doses and none in the treatment of @entity308 ( @entity308 ). METHODS: This open-label, pilot study was designed to investigate the efficacy, safety and tolerability of @entity837 in doses up to 50 mg in @entity308 . It was conducted in 60 primary care @entity1 with @entity308 who had not responded to adequate treatment with @entity837 . @entity1 were treated with escalating doses of @entity837 up to 50 mg for up to 32 weeks until they achieved remission (Montgomery-Asberg Depression Rating Scale [MADRS]  <= 8) or failed to tolerate the dose. RESULTS: Forty-two @entity1 (70%) completed the study. Twenty-one @entity1 (35%) achieved remission with 8 of the 21 @entity1 (38%) needing the 50 mg dose to achieve remission. Median time to remission was 24 weeks and median dose in remission was 30 mg. No significant safety issues were identified although tolerability appeared to decline above a dose of 40 mg with 26% of @entity1 unable to tolerate 50 mg. Twelve (20%) @entity1 had adverse events leading to discontinuation. The most common adverse events were @entity10 (35%), @entity390 , @entity294 and @entity11266 (all 25%). Minor mean weight gain was found during the study, which did not appear to be dose-related. Half of the @entity1 who completed the study chose to continue treatment with @entity837 rather than taper down the dose at 32 weeks. CONCLUSIONS: Dose escalation with @entity837 above 20 mg may have a useful role in the management of @entity1 with @entity308 , although further studies are needed to confirm this finding. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00785434.
