BACKGROUND: This prospective 105-site study was conducted to determine the rate of @entity410 and other serious adverse experiences associated with the therapeutic use of the sustained-release formulation of @entity752 ( @entity752 SR). METHOD: 3100 @entity1 with a DSM-III-R diagnosis of @entity308 without a current or past diagnosis of an @entity1277 and with no personal or family history of @entity410 disorders were treated for up to 8 weeks with @entity752 SR in an open-label study. Dosing was initiated at 50 mg b.i.d. and increased to a maximum of 150 mg b.i.d. unless not tolerated. @entity1 had the option to continue treatment with @entity752 SR (50 mg b.i.d. to 150 mg b.i.d.) in a continuation phase lasting up to 1 year. During the acute and continuation phases, @entity1 were evaluated for the occurrence of @entity410 and other serious adverse experiences. Clinical response to and tolerability of @entity752 SR were also evaluated. RESULTS: Three @entity1 each experienced a @entity410 associated with the therapeutic use of @entity752 SR during the acute and continuation phases combined. The observed @entity410 rate during the 8-week acute phase was 2 @entity410 in 3094 evaluable @entity1 , or 0.06%. The observed @entity410 rate for the acute and continuation phases combined was 3 @entity410 in 3094 @entity1 , or 0.10%. Survival analysis yielded a cumulative @entity410 rate of 0.08% for the acute phase and 0.15% for both phases combined. Two @entity1 who intentionally overdosed with @entity752 SR also experienced @entity410 ; however, these events were not included in calculations of the overall @entity410 rate. Therapeutic doses of @entity752 SR were well tolerated and clinically efficacious. CONCLUSION: The therapeutic use of @entity752 SR at total daily doses up to 300 mg/day in @entity308 @entity1 without predisposition to @entity410 is associated with a @entity410 rate that is well within the range observed with other marketed antidepressants.

A prospective safety surveillance study for @entity752 sustained-release in the treatment of XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity410 :: ('MESH:D012640', 'Disease') :: ['seizure', 'seizures'] @entity308 :: ('MESH:D003866', 'Disease') :: ['depressed', 'depression'] @entity1277 :: ('MESH:D001068', 'Disease') :: ['eating disorder'] @entity752 :: ('MESH:D016642', 'Chemical') :: ['bupropion']
@entity308 :: (MESH:D003866,Disease) :: ['depression']
