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Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (TEOSS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Olanzapine (enrollment closed in this treatment)
Molindone
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychotic Disorders, Schizophreniform Disorder

Eligibility Criteria

8 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 "*" OLA exclusion not applicable after 11/2005

Sites / Locations

  • Cambridge Health Alliance
  • University of North Carolina
  • University Hospitals of Cleveland
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

olanzapine

risperidone

molindone

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change From Baseline in Weight at Week 8
change in weight from baseline to week 8 in kg
Change From Baseline in Barnes Akathisia Scale at Week 8
Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.
Change From Baseline in Body Mass Index Change, kg/m2, at Week 8
Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.

Full Information

First Posted
February 4, 2003
Last Updated
February 7, 2014
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00053703
Brief Title
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Acronym
TEOSS
Official Title
Treatment of Schizophrenia and Related Disorders in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active psychotic symptoms. Participants are randomly assigned to receive risperidone (Risperdal), olanzapine (Zyprexa), or molindone (Moban) for 8 weeks. After 11/2005, no additional patients will be assigned to olanzapine treatment. Patients with significant improvement and without side effects continue maintenance therapy for another 44 weeks. Participants who show significant negative symptoms after 8 weeks may be started on a mood stabilizer or antidepressant. Weight gain, metabolic changes, neurocognition, functional outcome, psychotic symptoms, extrapyramidal side effects, and the ability to sustain effective therapy over time are assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychotic Disorders, Schizophreniform Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olanzapine
Arm Type
Active Comparator
Arm Description
oral olanzapine 5-20mg per day for up to 52 weeks
Arm Title
risperidone
Arm Type
Active Comparator
Arm Description
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Arm Title
molindone
Arm Type
Active Comparator
Arm Description
oral molindone from 10-140mg/daily for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Olanzapine (enrollment closed in this treatment)
Other Intervention Name(s)
Zyprexa
Intervention Description
oral olanzapine 5-20mg per day for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Molindone
Other Intervention Name(s)
Moban
Intervention Description
oral molindone from 10-140mg/daily for up to 52 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.
Description
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.
Time Frame
8 weeks
Title
Change From Baseline in PANSS Negative Symptom Subscale at Week 8
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Weight at Week 8
Description
change in weight from baseline to week 8 in kg
Time Frame
8 weeks
Title
Change From Baseline in Barnes Akathisia Scale at Week 8
Description
Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.
Time Frame
8 weeks
Title
Change From Baseline in Body Mass Index Change, kg/m2, at Week 8
Description
Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 "*" OLA exclusion not applicable after 11/2005
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linmarie Sikich, M.D.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
Cambridge Health Alliance
City
Medford
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17667476
Citation
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.
Results Reference
result
PubMed Identifier
17667477
Citation
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.
Results Reference
result
PubMed Identifier
20494268
Citation
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.
Results Reference
result
PubMed Identifier
32633541
Citation
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.
Results Reference
derived
PubMed Identifier
29920116
Citation
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.
Results Reference
derived
PubMed Identifier
28595147
Citation
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.
Results Reference
derived
PubMed Identifier
22525956
Citation
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.
Results Reference
derived
PubMed Identifier
18794207
Citation
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. Erratum In: Am J Psychiatry. 2008 Nov;165(11):1495.
Results Reference
derived

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Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

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