Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00053703
First received: February 4, 2003
Last updated: February 7, 2014
Last verified: February 2014

February 4, 2003
February 7, 2014
February 2002
May 2007   (final data collection date for primary outcome measure)
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.
psychotic symptoms
Complete list of historical versions of study NCT00053703 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Weight at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    change in weight from baseline to week 8 in kg
  • Change From Baseline in Barnes Akathisia Scale at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
Not Provided
 
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Treatment of Schizophrenia and Related Disorders in Children and Adolescents

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Risperidone
    oral risperidone 0.5mg to 6mg daily for up to 52 weeks
    Other Name: Risperdal
  • Drug: Olanzapine (enrollment closed in this treatment)
    oral olanzapine 5-20mg per day for up to 52 weeks
    Other Name: Zyprexa
  • Drug: Molindone
    oral molindone from 10-140mg/daily for up to 52 weeks
    Other Name: Moban
  • Active Comparator: olanzapine
    oral olanzapine 5-20mg per day for up to 52 weeks
    Intervention: Drug: Olanzapine (enrollment closed in this treatment)
  • Active Comparator: risperidone
    oral risperidone 0.5mg to 6mg daily for up to 52 weeks
    Intervention: Drug: Risperidone
  • Active Comparator: molindone
    oral molindone from 10-140mg/daily for up to 52 weeks
    Intervention: Drug: Molindone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
May 2007
May 2007   (final data collection date for primary outcome measure)

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

Both
8 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053703
U01 MH 615218-01A, U01MH062726, U01MH061355-01A1, U01MH062726-01, U01MH061464-01A1
Yes
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Study Chair: Linmarie Sikich, M.D. University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP