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1.
Int Clin Psychopharmacol ; 12 Suppl 1: S29-35, 1997 Feb.
Article in English | MEDLINE | ID: mdl-9179641

ABSTRACT

Evidence from clinical trials supports the claim that sertindole is a potent antipsychotic drug at a dose of 12-24 mg/day. Its action against positive symptoms is as potent as that of the traditional antipsychotic haloperidol. Its action against negative symptoms is significantly different from that of placebo and quantitatively larger than that of haloperidol. Its most distinctive characteristic is a reduction in motor side effects over a whole range of comparable drug and comparator doses. More work is needed to determine whether sertindole's actions against negative symptoms influence the primary or the secondary negative system. There are insufficient data at present to compare sertindole with the highly efficacious drug clozapine or the other new antipsychotic olanzapine.


Subject(s)
Antipsychotic Agents/therapeutic use , Imidazoles/therapeutic use , Indoles/therapeutic use , Schizophrenia/drug therapy , Antipsychotic Agents/adverse effects , Antipsychotic Agents/pharmacokinetics , Clinical Trials as Topic , Humans , Imidazoles/adverse effects , Imidazoles/pharmacokinetics , Indoles/adverse effects , Indoles/pharmacokinetics
2.
Arch Neurol ; 52(3): 281-6, 1995 Mar.
Article in English | MEDLINE | ID: mdl-7872882

ABSTRACT

OBJECTIVE: To compare the effectiveness and safety of divalproex sodium (Depakote) and placebo in the prophylaxis of migraine headache. DESIGN: Multicenter, double-blind, randomized, placebo-controlled investigation, having a 4-week, single-blind placebo baseline phase and a 12-week treatment phase (4-week dose adjustment, 8-week maintenance). SETTING: Eight headache/neurology clinics throughout the United States. PATIENTS: One hundred seven patients randomized to divalproex or placebo (2:1 ratio): 70 receiving divalproex and 37 receiving placebo. INTERVENTION: Divalproex and placebo dosages titrated in blinded fashion during dose adjustment period to achieve actual/sham trough valproate sodium concentrations of approximately 70 to 120 mg/L. MEASUREMENTS AND MAIN RESULTS: During the treatment phase, the mean migraine headache frequency per 4 weeks was 3.5 in the divalproex group and 5.7 in the placebo group (p < or = .001), compared with 6.0 and 6.4, respectively, during the baseline phase. Forty-eight percent of divalproex-treated patients and 14% of placebo-treated patients showed a 50% or greater reduction in migraine headache frequency from the baseline phase (P < .001). Among those with migraine headaches, divalproex-treated patients reported significantly less functional restriction than placebo-treated patients and used significantly less symptomatic medication per episode. No significant treatment group differences were observed in average peak severity or duration of individual migraine headaches. Treatment was stopped in 13% of divalproex-treated patients and 5% of placebo-treated patients because of intolerance (P, not significant). CONCLUSIONS: Divalproex is an effective prophylactic drug for patients with migraine headaches and is generally well tolerated.


Subject(s)
Migraine Disorders/drug therapy , Valproic Acid/therapeutic use , Adolescent , Adult , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Placebos , Valproic Acid/adverse effects
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