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The safety and effectiveness of most drugs are generally not as well established during clinical trials in children as in adults. Consequently, there is limited controlled research on the use of selective serotonin reuptake inhibitors (SSRIs) in children for the treatment psychoactive disorders. This limited experience makes it difficult to determine whether SSRIs are appropriate therapies in children, and if so, at what dose and for what length of therapy. However, an increasing base of experience is being developed to answer these questions. DeVane et al have reviewed some of the studies that provide evidence for the safe and effective use of these drugs in young patients, and some of these are described here briefly.

• In one study reviewed, 40 adolescents participated in a placebo-controlled, double-blind study of fluoxetine (Prozac) in major depression. A total of 32 patients were available for interview after the 8 weeks of treatment. The investigators concluded that there was a greater improvement in the fluoxetine group than in the control group; however, this difference was not statistically significant. Side effects were mostly mild, and the most frequent side effects were headache, vomiting, insomnia, and tremor.
• Another study was conducted in 15 adolescents with major depression. After the treatment period with selective serotonin reuptake inhibitors was over, it was noted that 64% of the children showed a greater than 50% change on the Hamilton Rating Scale for Depression (HAM-D) and 73% showed improvement by the Clinical Global Impression (CGI) scale.
• The use of fluvoxamine (Luvox) has been evaluated in 6 young patients for the treatment of major depressive disorders. All patients showed a significant decrease in Beck Depression Inventory (BDI) scores.
• fluvoxamine (Luvox) was assessed in 14 adolescents with a diagnosis of OCD by Apter et al. Y-BOCS scores improved significantly after 6 weeks of active treatment. Side effects included nausea, agitation, and insomnia. Treatment had to be discontinued in 4 patients because of side effects.
• While doing chart reviews of 31 inpatient children, investigators in another study found that 74% of the patients showed improvement as rated using the CGI following treatment with fluoxetine (Prozac) at doses that ranged from 20-80 mg/day for 7-89 days. However, 43% had minimal improvement or no change.
• A randomized, double-blind, placebo-controlled, fixed dose (20 mg/day) trial of fluoxetine (Prozac) in 14 patients with obsessive compulsive disorder (OCD) whose age ranged from 8-15 years showed that fluoxetine (Prozac) was safe and effective for the short-term treatment of children with OCD. Scores on the Yales-Brown Obsessive Compulsive Scale (Y-BOCS) decreased 44% after fluoxetine (Prozac) treatment compared with a 27% decrease after placebo treatment. Side effects were mild.
• Another study evaluated the use of fluoxetine (Prozac) in 11 boys with a diagnosis of Tourette’s syndrome. An improvement was found in terms of tic severity, attention abilities, and social functioning. However these differences were not statistically significant.
• fluoxetine (Prozac) appears to be effective in treating eating disorders such as anorexia and bulimia. However, in the studies reviewed by DeVane et al., either the patient population was small or the study design was poor. Hence, a definitive conclusion can not be drawn.
• Selective serotonin reuptake inhibitors have also been studied in the treatment of attention-deficit/hyperactivity disorder (ADHD). In one study, fluoxetine (Prozac) was shown to cause a moderate improvement in 58% of patients evaluated. However, 42% had minimal improvement.

The side effects caused by SSRIs in adolescents varied widely. Some trials suggest that they are mild whereas others concluded that the side effects were significant. Some of these side effects include motor restlessness, sleep disturbances, social disinhibition, mania or hypomania, and psychosis. The most common side effects that were experienced include hypomania-like symptoms, irritability, gastrointestinal upset, and insomnia.

The use of selective serotonin reuptake inhibitors in children at present is supported by preliminary findings. There are case reports and other small studies that suggest that they may be useful. However, as indicated by the study conducted by Simeon et al, which was well-designed, there was no statistically significant improvement with the use of SSRIs. Recent initiatives by manufacturers of selective serotonin reuptake inhibitors to better define the value of these drugs in pediatric indications have, in fact, resulted in the approval of at least one of these drugs (fluvoxamine) for the treatment of childhood obsessive-compulsive disorder. As physicians gain experience with the use of SSRIs in clinical practice, and as the results of larger, well-designed controlled clinical studies become available, a more comprehensive understanding of the role of these drugs in childhood psychiatric disorders will emerge.