Double-Blind Comparison of First- and Second-Generation Antipsychotics in Early-Onset Schizophrenia and Schizo-affective Disorder: Findings From the Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) Study

Linmarie Sikich, M.D., Jean A. Frazier, M.D., Jon McClellan, M.D., Robert L. Findling, M.D., Benedetto Vitiello, M.D., Louise Ritz, M.B.A., Denisse Ambler, M.D., Madeline Puglia, B.A., Ann E. Maloney, M.D., Emily Michael, B.A., Sandra De Jong, M.D., Karen Slifka, R.N., C.S., Nancy Noyes, C.P.N.P., C.S., Stefanie Hlastala, Ph.D., Leslie Pierson, M.P.H., Nora K. McNamara, M.D., Denise Delporto-Bedoya, M.A., Robert Anderson, B.S., Robert M. Hamer, Ph.D., and Jeffrey A. Lieberman, M.D.
In total, 119 youth were randomly assigned to treatment. Of these subjects, 116 received at least one dose of treatment and thus were available for analysis. No significant differences were found among treatment groups in response rates (molindone: 50%; olanzapine: 34%; risperidone: 46%) or magnitude of symptom reduction. Olanzapine and risperidone were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia. Conclusions: Risperidone and olanzapine did not demonstrate superior efficacy over molindone for treating early-onset schizophrenia and schizoaffective disorder. Adverse effects were frequent but differed among medications. The results question the nearly exclusive use of second-generation antipsychotics to treat early-onset schizophrenia and schizoaffective disorder. The safety findings related to weight gain and metabolic problems raise important public health concerns, given the widespread use of second-generation antipsychotics in youth for nonpsychotic disorders.

Double-Blind Maintenance Safety and Effectiveness Findings From the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) Study

"Of the 116 youths randomized in the acute trial, 54 entered maintenance treatment (molindone, n = 20; olanzapine, n = 13; risperidone, n = 21). Fourteen (26%) completed 44 weeks of treatment."

Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS): Demographic and Clinical Characteristics

"A total of 119 youths were enrolled."

Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS): RatIonale, Design, and Methods

"From February 2002 to May 2006, 476 youths were screened, 173 were further evaluated, and 119 were randomized"

the following is a literature review study, not an article specific to the TEOSS drug trial.
Efficacy and Tolerability of Second-Generation Antipsychotics in Children and Adolescents With Schizophrenia

Sanjiv Kumra,^1,² Joel V. Oberstar,² Linmarie Sikich,³ Robert L. Findling,⁴Jon M. McClellan,⁵ Sophia Vinogradov,⁶ and S. Charles Schulz "Although the pathophysiology of schizophrenia remains unclear, it has been hypothesized that increased dopaminergic neurotransmission in the mesolimbic pathways produces the positive symptoms of the disease.¹⁷^,¹⁸ Based on this working hypothesis, it is thought that antipsychotic medications work by blocking dopamine D₂ receptors, thus dampening psychotic symptoms."

The above couple of sentences demonstrate the lack of scientific thinking and research that is practiced by psychiatry. It is after learning the action of the drugs themselves, which led to the hypothesis that positive symptoms are due to "increased dopamoinergic neuro transmission in the mesolimbic pathways"

Neurocognition in early-onset schizophrenia and schizoaffective disorders.

Hooper SR, Giuliano AJ, Youngstrom EA, Breiger D, Sikich L, Frazier JA, Findling RL, McClellan J, Hamer RM, Vitiello B, Lieberman JA.

J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):52-60.

PMID:: 20215926; [PubMed - indexed for MEDLINE]

The treatment

"We compared the baseline neuropsychological functioning of youth with schizophrenia (SZ, n = 79) to those with schizoaffective disorder (SA, n = 40)"

Treatment of early-onset schizophrenia spectrum disorders (TEOSS): demographic and clinical characteristics

Source

"A total of 119 youths were enrolled."

Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study.

Findling RL, Johnson JL, McClellan J, Frazier JA, Vitiello B, Hamer RM, Lieberman JA, Ritz L, McNamara NK, Lingler J, Hlastala S, Pierson L, Puglia M, Maloney AE, Kaufman EM, Noyes N,Sikich L. "Of the 116 youths randomized in the acute trial, 54 entered maintenance treatment"

Double-Blind Comparison of First- and Second-Generation

Antipsychotics in Early-Onset Schizophrenia and Schizoaffective

Disorder: Findings From the Treatment of Early-

Onset Schizophrenia Spectrum Disorders (TEOSS) Study pdf download

Results: "In total, 119 youth were randomly assigned to treatment. Of these subjects, 116 received at least one dose of treatment and thus were available for analysis."

Discussion a couple of excerpts:

"Second-generation antipsychotics olanzapine and risperidone did not demonstrate superior efficacy to molindone in the treatment of children and adolescents with early-onset schizophrenia and schizoaffective disorder. Across all three treatments, more than half the participants failed to achieve an adequate response after 8 weeks of therapy."

"At the time the study was initiated, there were significant ethical concerns about utilizing any first-generation antipsychotic in comparison with second-generation antipsychotics, because second-generation antipsychotic treatment was the standard of care for early-onset schizophrenia and schizoaffective disorder."

The above sentence begs the question, "WHY are SGAs considered the Standard of Care? What the hell is this supposed "standard" based on?!

via Find the Data:

Status: Completed
Start Date: 02/01/2002
Completion Date: 05/01/2007
Enrollment 119

Pages

Dec 23, 2012

TEOSS