NCT00053703

Brief Summary

This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 4, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

March 26, 2014

Completed
Last Updated

March 26, 2014

Status Verified

February 1, 2014

Enrollment Period

5.2 years

First QC Date

February 4, 2003

Results QC Date

September 16, 2013

Last Update Submit

February 7, 2014

Conditions

Schizophrenia

Keywords

Psychotic DisordersSchizophreniform Disorder

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks

    Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores \> that 60 are considered clinically significant.

    8 weeks

  • Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.

    The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.

    8 weeks

  • Change From Baseline in PANSS Negative Symptom Subscale at Week 8

    The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.

    8 weeks

Secondary Outcomes (3)

  • Change From Baseline in Weight at Week 8

    8 weeks

  • Change From Baseline in Barnes Akathisia Scale at Week 8

    8 weeks

  • Change From Baseline in Body Mass Index Change, kg/m2, at Week 8

    8 weeks

Study Arms (3)

olanzapine

ACTIVE COMPARATOR

oral olanzapine 5-20mg per day for up to 52 weeks

Drug: Olanzapine (enrollment closed in this treatment)

risperidone

ACTIVE COMPARATOR

oral risperidone 0.5mg to 6mg daily for up to 52 weeks

Drug: Risperidone

molindone

ACTIVE COMPARATOR

oral molindone from 10-140mg/daily for up to 52 weeks

Drug: Molindone

Interventions

RisperidoneDRUG

oral risperidone 0.5mg to 6mg daily for up to 52 weeks

Also known as: Risperdal
risperidone
Olanzapine (enrollment closed in this treatment)DRUG

oral olanzapine 5-20mg per day for up to 52 weeks

Also known as: Zyprexa
olanzapine
MolindoneDRUG

oral molindone from 10-140mg/daily for up to 52 weeks

Also known as: Moban
molindone

Eligibility Criteria

Age8 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms
  • Free of depot antipsychotic medication for at least 6 months. Oral antipsychotic medication at entry into the study is allowed, provided the participant has not had an adequate trial during the present episode of psychosis.
  • If taking antidepressant or mood stabilizing medication, stable dosing for at least 30 days prior to entry.
  • Good physical health

You may not qualify if:

  • Risperidone (RIS), olanzapine (OLA)\*, or molindone (MOL) for 8 weeks or more during THIS episode, with 2 weeks at the maximal dose (6 mg/day of RIS, 20 mg/day of OLA, or 140 mg/day of MOL)
  • If using antidepressant and/or mood stabilizing medications, treatment for fewer than 30 days immediately before entry
  • Intolerance or nonresponse to RIS, OLA\*, or MOL during any previous treatment
  • Bipolar affective disorder,post traumatic stress disorder, personality disorder, or psychosis not otherwise specified
  • Currently meeting Diagnostic and Statistical Manual version IV (DSM IV) criteria for major depression episode
  • DSM IV criteria for substance abuse or dependence with intention to continue illicit substance abuse
  • Endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics
  • Mental retardation
  • Risk of suicide or homicide that is not adequately controlled in the current setting
  • Pregnancy or refusal to practice contraception during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cambridge Health Alliance

Medford, Massachusetts, 02155, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (8)

  • McCLELLAN J, Sikich L, Findling RL, Frazier JA, Vitiello B, Hlastala SA, Williams E, Ambler D, Hunt-Harrison T, Maloney AE, Ritz L, Anderson R, Hamer RM, Lieberman JA. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): rationale, design, and methods. J Am Acad Child Adolesc Psychiatry. 2007 Aug;46(8):969-978. doi: 10.1097/CHI.0b013e3180691779.

    PMID: 17667476RESULT

  • Frazier JA, McCLELLAN J, Findling RL, Vitiello B, Anderson R, Zablotsky B, Williams E, McNAMARA NK, Jackson JA, Ritz L, Hlastala SA, Pierson L, Varley JA, Puglia M, Maloney AE, Ambler D, Hunt-Harrison T, Hamer RM, Noyes N, Lieberman JA, Sikich L. Treatment of early-onset schizophrenia spectrum disorders (TEOSS): demographic and clinical characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Aug;46(8):979-988. doi: 10.1097/chi.0b013e31807083fd.

    PMID: 17667477RESULT

  • 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. Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):583-94; quiz 632. doi: 10.1016/j.jaac.2010.03.013. Epub 2010 May 1.

    PMID: 20494268RESULT

  • Taylor JH, Appel S, Eli M, Alexander-Bloch A, Maayan L, Gur RE, Bloch MH. Time to Clinical Response in the Treatment of Early Onset Schizophrenia Spectrum Disorders Study. J Child Adolesc Psychopharmacol. 2021 Feb;31(1):46-52. doi: 10.1089/cap.2020.0030. Epub 2020 Jul 1.

    PMID: 32633541DERIVED

  • Taylor JH, Jakubovski E, Gabriel D, Bloch MH. Predictors and Moderators of Antipsychotic-Related Weight Gain in the Treatment of Early-Onset Schizophrenia Spectrum Disorders Study. J Child Adolesc Psychopharmacol. 2018 Sep;28(7):474-484. doi: 10.1089/cap.2017.0147. Epub 2018 Jun 19.

    PMID: 29920116DERIVED

  • Gabriel D, Jakubovski E, Taylor JH, Artukoglu BB, Bloch MH. Predictors of treatment response and drop out in the Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) study. Psychiatry Res. 2017 Sep;255:248-255. doi: 10.1016/j.psychres.2017.05.038. Epub 2017 May 30.

    PMID: 28595147DERIVED

  • Frazier JA, Giuliano AJ, Johnson JL, Yakutis L, Youngstrom EA, Breiger D, Sikich L, Findling RL, McClellan J, Hamer RM, Vitiello B, Lieberman JA, Hooper SR. Neurocognitive outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders study. J Am Acad Child Adolesc Psychiatry. 2012 May;51(5):496-505. doi: 10.1016/j.jaac.2012.02.001. Epub 2012 Mar 13.

    PMID: 22525956DERIVED

  • Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, Puglia M, Maloney AE, Michael E, De Jong S, Slifka K, Noyes N, Hlastala S, Pierson L, McNamara NK, Delporto-Bedoya D, Anderson R, Hamer RM, Lieberman JA. 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. Am J Psychiatry. 2008 Nov;165(11):1420-31. doi: 10.1176/appi.ajp.2008.08050756. Epub 2008 Sep 15.

    PMID: 18794207DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

RisperidoneOlanzapineMolindone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndoles

Limitations and Caveats

The most significant weakness of this study was the sample size, which was sufficient only to detect large differences across the three treatments and limited our ability to identify predictors of response or adverse effects.

Results Point of Contact

Title
Linmarie Sikich, MD
Organization
UNC Chapel Hill
lsikich@med.unc.edu
919-972-9744

Study Officials

  • Linmarie Sikich, M.D.

    University of North Carolina, Chapel Hill

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2003

First Posted

February 5, 2003

Study Start

February 1, 2002

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

March 26, 2014

Results First Posted

March 26, 2014

Record last verified: 2014-02

Locations

US(4)