Psychopharmacol Bull
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Psychopharmacol Bull · Jan 1992
Randomized Controlled Trial Clinical TrialSide effects associated with lithium and placebo administration in aggressive children.
This study represents a secondary data analysis of two double-blind and placebo-controlled clinical trials of lithium, performed to contrast side effects associated with lithium administration to those associated with placebo. The sample consisted of 91 hospitalized children, aged 5.12 to 12.92 years (mean 9.16), diagnosed as having conduct disorder characterized by severe aggressiveness and explosiveness. Daily doses of lithium ranged from 250 to 2100 mg. ⋯ Increased aggressiveness was observed in 4 children who received placebo. Vomiting, headache, and stomachache were the most common side effects experienced by patients in both lithium and placebo groups. However, more patients experienced these side effects in the lithium group than in the placebo group.
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Psychopharmacol Bull · Jan 1992
Carbamazepine in hospitalized aggressive conduct disorder children: an open pilot study.
Ten subjects completed an open pilot study of carbamazepine in hospitalized aggressive and explosive children diagnosed as having conduct disorder. The subjects (9 boys, 1 girl) ranged in age from 5.25 to 10.92 years (mean = 8.27). Ratings were done at the end of a 1-week baseline period and after 3 weeks of treatment with carbamazepine. ⋯ The optimal daily doses of carbamazepine ranged from 600 to 800 mg (mean = 630); plasma levels at post-treatment rating ranged from 4.8 to 10.4 micrograms/mL (mean = 6.2). Administration of carbamazepine was associated with clinically and statistically significant declines in the target symptoms of aggressiveness and explosiveness. These results are promising and suggest that a critical assessment of the efficacy and safety of carbamazepine is warranted under double-blind and placebo-controlled conditions in this population.
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Psychopharmacol Bull · Jan 1991
ReviewA note on randomization and selection bias in maintenance therapy clinical trials.
In this article we demonstrate that even in randomized controlled clinical trials, unobserved confounding variables can bias the outcome of a study. For the case of a two-phase maintenance therapy trial where patients who respond to treatment during the acute phase are then randomized to a maintenance therapy, we show explicitly the role that confounding may play in biasing the interpretation of the results of such a trial. We suggest an alternative design to deal with the problem of a selection effect for treatment responders in the acute phase of the trial by randomizing patients at the outset of the study to both an acute and maintenance therapy.
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Psychopharmacol Bull · Jan 1991
Randomized Controlled Trial Clinical TrialPredictors of side effects associated with lithium administration in children.
Data were pooled from three controlled and double-blind studies of lithium carbonate involving a total of 48 hospitalized children, and secondary data analyses were conducted. The objective was to assess whether there is a relationship between a child's chronological age and side effects associated with lithium administration. ⋯ For the entire sample of 48 children, the effect of age on side effects was statistically significant (p = .057); younger children had more side effects than older children. This relationship continued to hold after adjustment for weight, serum lithium levels, optimal dose, and duration of optimal dose.
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Psychopharmacol Bull · Jan 1990
Randomized Controlled Trial Clinical TrialA placebo- and imipramine-controlled study of paroxetine.
The objective of this study was to compare the safety and efficacy of paroxetine with imipramine and placebo in depressed outpatients. Following a 4- to 14-day placebo washout, patients were randomized into treatment groups and received study compound for up to 42 days. ⋯ Significantly more imipramine (75%) than paroxetine (35%) or placebo (23%) patients reported anticholinergic side effects, including blurred vision (5%, 0%, and 0%, respectively), constipation (35%, 8%, and 15%, respectively), and dry mouth (63%, 25%, and 15%, respectively). The data from this study indicated that paroxetine is a safe, well-tolerated, effective treatment for major depressive disorder.