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Psychiatry: Drugs

Volume 463: debated on Tuesday 17 July 2007

To ask the Secretary of State for Health pursuant to the answer of 14 May 2007, Official Report, column 623W, on Psychiatry: Drugs, how his Department measured the efficacy of the use of Prozac on children; what baseline was used; and what scientific methodology was employed. (148193)

The Medicines and Healthcare products Regulatory Agency evaluated data in two double-blind placebo-controlled trials submitted by the applicant which included children and adolescents aged eight to 18 years. (A double-blind trial is one where the person administering and receiving the medication does not know what the medication is placebo or active treatment in this case). The duration of these trials was eight weeks and one year. In addition, there was a trial published in the literature which included adolescents aged 12 to 17 years. It was a double-blind placebo-controlled trial and included comparator groups with cognitive behaviour therapy alone or a combination of fluoxetine and CBT.

Various rating scales were used to measure efficacy and these included the children’s depression rating scale—revised, the clinical global impressions of severity, clinical global impressions of improvement, Montgomery Asberg depression rating scale and others.

The measurement of efficacy was a clinically significant change in the severity of depression as measured on a rating scale developed specifically to diagnose depression and determine its severity. The baseline used was the child’s depression score prior to treatment which had to indicate depression of at least ‘moderate’ severity.

Differences between treatment and placebo were evaluated using statistical methodology and clinical assessment.