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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Risperidone
Drug: Olanzapine (enrollment closed in this treatment)
Drug: Molindone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 116
Study Start Date: February 2002
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: olanzapine
oral olanzapine 5-20mg per day for up to 52 weeks
Drug: Olanzapine (enrollment closed in this treatment)
oral olanzapine 5-20mg per day for up to 52 weeks
Other Name: Zyprexa
Active Comparator: risperidone
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Drug: Risperidone
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Other Name: Risperdal
Active Comparator: molindone
oral molindone from 10-140mg/daily for up to 52 weeks
Drug: Molindone
oral molindone from 10-140mg/daily for up to 52 weeks
Other Name: Moban

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.

  Eligibility

Ages Eligible for Study:   8 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053703

Locations
United States, Massachusetts
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Study Chair: Linmarie Sikich, M.D. University of North Carolina, Chapel Hill
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Linmarie Sikich, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00053703     History of Changes
Obsolete Identifiers: NCT00030251, NCT00043290
Other Study ID Numbers: U01 MH 615218-01A, U01MH062726, U01MH061355-01A1, U01MH062726-01, U01MH061464-01A1
Study First Received: February 4, 2003
Results First Received: September 16, 2013
Last Updated: February 7, 2014
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Psychotic Disorders
Schizophreniform Disorder

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Molindone
Olanzapine
Risperidone
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014