August 17

Study: Antipsychotics Not Effective for Childhood Schizophrenia

A meta-analysis of first generation neuroleptics / antipsychotics (FGAs–e.g., Haldol, thorazine) vs. Second generation so-called ‘atypical antipsychotics’ (SGAs–Zyprexa, Risperdal, Seroquel, others) shows that even in cases where atypical antipsychotics were prescribed for legitimate, FDA-approved conditions–i.e., schizophrenia–the drugs were shown not to be safe or effective.

Industry’s blockbuster sellers–the atypical antipsychotics performed WORSE than their cheaper, non-patented precursors. And the atypicals had MORE
adverse side-effects such as, acute weight gain and somnolence.  Both the typical (FGAs) and the atypical (SGAs) caused extrapyramidal side effects in
57% of children.

The authors acknowledge a flaw in the meta-analysis is “exclusion of
unpublished data, omission of which may have, conceivably, led to
overestimation of response rates.”
Indeed, until independent analysts gained access to the SSRI antidepressant
unpublished data–those drugs were touted as “wonder drugs”–the data,
however, showed that their benefit was largely due to the placebo illusion.

Contact: Vera Hassner Sharav
Antipsychotic Therapy for Childhood Schizophrenia Lacks Evidence Base: Child and Adolescent Psychiatry Viewpoint
Randall F. White, MD, FRCPC; Andro Giorgadze, MD
Medscape Psychiatry & Mental Health.  2006;11(2) C2006 Medscape
Posted 08/07/2006

Antipsychotics in Early-Onset Schizophrenia: Systematic Review and Meta-analysis
Armenteros JL, Davies M
Eur Child Adolesc Psychiatry. 2006;15:141-148

The United States Food and Drug Administration (FDA) has not approved any
antipsychotic drugs for treating childhood schizophrenia; yet, clinicians
routinely use medications for this disorder. To examine the available
evidence, published articles reporting prospective treatment of subjects
5-18 years old diagnosed with schizophrenia were identified and then rated,
using instruments to measure outcomes. Of 26 articles containing primary
data, 15 met inclusion criteria:

1 case series;
2 randomized, double-blind, placebo-controlled trials;
7 were open trials; and
5 randomized, either single- or double-blind, non-placebo-controlled trials.

The studies included a total of 294 subjects; 209 received first-generation
antipsychotics (FGAs), 85 received second-generation antipsychotics (SGAs),
and 36 received placebo. In FGA studies, the mean response rate was 72.3%
with a range of 35% to 93%. In SGA studies, the mean response rate was 55.7%
with a range of 13% to 75%. The difference in response rate comparing the 2
classes of medication demonstrated a significant trend (P < .10). In
analysis of studies that used the Brief Psychiatric Rating Scale as an
outcome measure, the effect size for FGAs vs SGAs was 0.36 in favor of FGAs.

Analysis of adverse effects found mean weight gain of 1.4 kg with FGAs and
4.5 kg with SGAs, more sedation with SGAs, but a similar rate of
extrapyramidal side effects in the 2 medication classes of approximately

The finding of better treatment response with FGAs may be surprising, but
the studies of SGAs were of lower quality. The 2 best-designed studies
employed FGAs. Furthermore, as the investigators suggest, the subjects of
SGA studies may have failed treatment with FGAs and may have been more
treatment-resistant. A flaw in the meta-analysis is exclusion of unpublished
data, omission of which may have, conceivably, led to overestimation of
response rates.

The major finding of this meta-analysis is that the evidence base for
pharmacotherapy of childhood schizophrenia is poor, reflecting a paucity of
medication trials most of which are of low quality. The data on adverse
effects is likewise deficient and lacks standardized reporting. The
conclusion for clinicians is that FGAs seem to be an appropriate and
relatively safe choice, but long-term outcomes and risk of tardive
dyskinesia are not addressed in this article.

Randall White, MD, Psychiatrist, St. Paul’s Hospital, Vancouver, Canada, British Columbia; Andro Giorgadze, MD, Staff Physician, Sumter Regional
Hospital, Americus, Georgia

Disclosure: Randall F. White, MD, has disclosed that he owns stock, stock options, or bonds in Roche Holding AG, GlaxoSmithKline PLC, Novartis AG,
Merck KGaA, sanofi-aventis, and Novo Nordisk.

Disclosure: Andro Giorgadze, MD, has disclosed no relevant financial relationships.

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