Table 2. Evidence for pharmacological treatments for pediatric OCD.
| Authors, country, year | N | Outcome measures | Gender, ages | Study design, duration | Outcomes |
|---|---|---|---|---|---|
| Clomipramine | |||||
| DeVeaugh-Geiss, USA, 1992, (148) | 60 | CY-BOCS | Male and female patients ages 10–17 with DSM-III diagnosis of OCD with CY-BOCS >16 | Randomized to 8-week trial of clomipramine vs. placebo | Average decrease in CY-BOCS of 37% of clomipramine vs. 8% in the placebo group |
| de Haan, Holland, 1998, (134) | 22 | CY-BOCS and Leyton Obsessional Inventory-Child Version (LOI-CV) | Male and female patients ages 8–18 with DSM-III diagnosis of OCD | Randomized to behavior therapy or clomipramine (mean dose of 2.5 mg/kg) for 12 weeks. Behavior therapy involved weekly sessions of exposure and response prevention | Participants in behavior therapy arm had 59.9% mean improvement from baseline CY-BOCS total compared to 33.4% in clomipramine group. No significant difference on the LOI-CV between the two treatments |
| Fluoxetine | |||||
| Riddle, USA, 1992, (149) | 14 | CY-BOCS | Male and female patients ages 8–15 with DSM-III diagnosis of OCD and CGI-S >4 | Randomized to fixed dose of fluoxetine (20 mg daily) or placebo. Study lasted 20 weeks with crossover at 8 weeks | At 8 weeks, fluoxetine treatment group had an average decrease in CY-BOCS total score of 44% compared to 27% in placebo group |
| Geller, USA, 2001, (153) | 103 | CY-BOCS | Male and female patients ages 7–17 with DSM-IV diagnosis of OCD and CY-BOCS >16 | Randomized to fluoxetine (10 mg daily x 2 weeks, then 20 mg daily) or placebo. At 4 weeks and at 7 weeks, fluoxetine dose was increased by 20 mg daily for non-responders | Fluoxetine group had a significant reduction in OCD severity over the placebo group. Fluoxetine and placebo groups had a similar rate of discontinuation due to adverse effects |
| Liebowitz, USA, 2002, (154) | 43 | CY-BOCS, CGI-I | Male and female patients ages 6–18 with DSM-IV diagnosis of OCD and CY-BOCS >16 | Randomized to fluoxetine or placebo for 8 weeks. Responders continued treatment for an additional 8-week maintenance period | No statistical difference in CY-BOCS at 8 weeks, but by 16 weeks, fluoxetine group had significantly lower CY-BOCS compared to placebo. At 16 weeks, 57% of fluoxetine and 27% of placebo patients were much or very much improved per CGI-I scale. No patients withdrew from the study due to adverse effects |
| Fluvoxamine | |||||
| Neziroglu, USA, 2000, (150) | 10 | CY-BOCS | Male and female patients ages 10–17 with DSM-IV diagnosis of OCD | All patients started on fluvoxamine for 10 weeks. After initial 10 weeks, patients randomized to continue on fluvoxamine alone or continue on fluvoxamine and receive 20 sessions of behavioral therapy. Both groups received treatment for 1 year | By week 10, 80% patients had significant improvement on CY-BOCS. Patients in combination treatment demonstrated significantly more improvement vs. patients on fluvoxamine alone |
| Riddle, USA, 2001, (151) | 14 | CY-BOCS | Male and female patients ages 8–17 with DSM-III diagnosis of OCD and CY-BOCS >16 | Randomized to fluvoxamine (50–200 mg/day) or placebo for 10 weeks. At 6 weeks, non-responders could choose to withdraw from double-blind phase and enter open-label trial of fluvoxamine | Significant difference in percentage of responders (defined as 25% or greater reduction in CY-BOCS)—42% of fluvoxamine group vs. 26% of placebo group |
| Paroxetine | |||||
| Geller, USA, 2004, (152) | 203 | CY-BOCS | Male and female patients aged 7–17 with DSM-IV diagnosis of OCD | Randomized to Paroxetine (10–50 mg/day) vs. placebo for 10 weeks | −8.78 vs. −5.34 points on CY-BOCS at week 10 (P=0.002) |
| Sertraline | |||||
| March, USA, 1998, (135) | 187 | CY-BOCS. NIMH GOCS. CGI-S. CGI-I | Male and female patients ages 6–17 with DSM-III diagnosis of OCD and GOCS >7 | Randomized to sertraline (up to 200 mg daily) or placebo. Sertraline dose was titrated during the first 4 weeks of treatment, then sertraline recipients were maintained on the same dose for an additional 8 weeks | Sertraline patients had significantly greater improvement compared to placebo patients on all measures—on CY-BOCS (adjusted mean, −6.8 vs. −3.4, P=0.005), on NIMH GOCS (−2.2 vs. −1.3, P=0.02), and on CGI-I (2.7 vs. 3.3, P=0.002) |
| March, USA, 2006, (155) | 112 | CY-BOCS | Male and female patients ages 7–17 with DSM-IV diagnosis of OCD and CY-BOCS >16 | Randomized to pill placebo, CBT, sertraline, or combined CBT and sertraline for 12 weeks | The CBT, sertraline, and combination group had a significantly significant response over the placebo group. Combination treatment was more efficacious than either only CBT or only sertraline. Results of CBT alone group did not differ significantly from sertraline alone group |
CY-BOCS, Children’s Yale-Brown Obsessive-Compulsive Scale; CGI-S, Clinical Global Impression-Severity scale; CGI-I, Clinical Global Impression-Improvement scale; NIMH GOCS, The National Institute of Mental Health Global Obsessive-Compulsive Scale.