SchizophreniaPhase 4TEOSSNCT00053703

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

A Phase 4 study testing Risperidone, Olanzapine (enrollment closed in this treatment) and Molindone in people with Schizophrenia, run by University of North Carolina, Chapel Hill at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 8 to 19 years
Conditions the study is for: Schizophrenia
What is being tested?: Risperidone, Olanzapine (enrollment closed in this treatment) and Molindone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 4 sitesUnited States
Study dates: Feb 2002to May 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of North Carolina
Chapel Hill, North Carolina, 27514
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cambridge Health Alliance
Medford, Massachusetts, 02155
University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents

Read the 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.

Conditions: Schizophrenia
Being tested: Risperidone, Olanzapine (enrollment closed in this treatment), Molindone
Keywords: Psychotic Disorders, Schizophreniform Disorder
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisperidoneDrug
Also called Risperdal
oral risperidone 0.5mg to 6mg daily for up to 52 weeks
Olanzapine (enrollment closed in this treatment)Drug
Also called Zyprexa
oral olanzapine 5-20mg per day for up to 52 weeks
MolindoneDrug
Also called Moban
oral molindone from 10-140mg/daily for up to 52 weeks

Study groups in NCT00053703
Study group	Role	What they receive
olanzapine	Active comparator	oral olanzapine 5-20mg per day for up to 52 weeks Receives: Drug: Olanzapine (enrollment closed in this treatment)
risperidone	Active comparator	oral risperidone 0.5mg to 6mg daily for up to 52 weeks Receives: Drug: Risperidone
molindone	Active comparator	oral molindone from 10-140mg/daily for up to 52 weeks Receives: Drug: Molindone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (3)

Change From Baseline in Weight at Week 8
change in weight from baseline to week 8 in kg
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2002May 2007

First posted5 Feb 2003 (estimated)
Study startFeb 2002
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00053703
Sponsor's protocol ID: U01 MH 615218-01A
Other IDs: U01MH062726, U01MH061355-01A1, U01MH062726-01, U01MH061464-01A1
Acronym: TEOSS
Status last verified: Feb 2014
First submitted: 4 Feb 2003
Last updated: 26 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 17667476
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.
PubMed 17667477
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.
PubMed 20494268
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.
PubMed 32633541
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.
PubMed 29920116
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.
PubMed 28595147
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.
PubMed 22525956
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.
PubMed 18794207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Schizophrenia and Related Disorders in Children and Adolescents
ClinicalTrials.gov ID: NCT00053703
Acronym / sponsor ID: TEOSS / U01 MH 615218-01A
Conditions: Schizophrenia
Keywords: Psychotic Disorders, Schizophreniform Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Feb 2002
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 5 Feb 2003 (estimated)
Results: Posted 26 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
olanzapine	Active comparator	Drug: Olanzapine (enrollment closed in this treatment)oral olanzapine 5-20mg per day for up to 52 weeks
risperidone	Active comparator	Drug: Risperidoneoral risperidone 0.5mg to 6mg daily for up to 52 weeks
molindone	Active comparator	Drug: Molindoneoral molindone from 10-140mg/daily for up to 52 weeks

Who may qualify

Ages: 8 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RisperidoneAlso: Risperdaloral risperidone 0.5mg to 6mg daily for up to 52 weeks	Drug	risperidone
Olanzapine (enrollment closed in this treatment)Also: Zyprexaoral olanzapine 5-20mg per day for up to 52 weeks	Drug	olanzapine
MolindoneAlso: Mobanoral molindone from 10-140mg/daily for up to 52 weeks	Drug	molindone

Primary outcome

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks
Time frame: 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.
Time frame: 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
Time frame: 8 weeks
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.

3 secondary outcomes

Change From Baseline in Weight at Week 8
Time frame: 8 weeks
Change From Baseline in Barnes Akathisia Scale at Week 8
Time frame: 8 weeks
Change From Baseline in Body Mass Index Change, kg/m2, at Week 8
Time frame: 8 weeks

Results and safety

Results posted to the registry on 26 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olanzapine	35	17
Risperidone	41	28
Molindone	40	25

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

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Olanzapine n = 35	Risperidone n = 41	Molindone n = 40
Value	-26.6 (17.8)	-23.7 (25.5)	-27.0 (17.7)

Olanzapine vs Risperidone vs Molindone: p = 0.05, Mixed Models Analysis

Population analysed: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Primary outcome: Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Olanzapine n = 35	Risperidone n = 41	Molindone n = 40
Value	-8.9 (6.0)	-8.4 (8.1)	-8.8 (5.4)

Population analysed: All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Primary outcome: Change From Baseline in PANSS Negative Symptom Subscale at Week 8

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Olanzapine n = 35	Risperidone n = 41	Molindone n = 40
Value	-5.3 (7.6)	-5.1 (7.8)	-5.8 (6.8)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks, Systematic events. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olanzapine	2 of 35 (5.7%)	26 of 35 (74.3%)	Not reported
Risperidone	4 of 41 (9.8%)	35 of 41 (85.4%)	Not reported
Molindone	2 of 40 (5%)	36 of 40 (90%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17667476McCLELLAN 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 publication: PubMed 17667477Frazier 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 publication: PubMed 20494268Findling 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.
Derived from this study: PubMed 32633541Taylor 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.
Derived from this study: PubMed 29920116Taylor 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.
Derived from this study: PubMed 28595147Gabriel 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.
Derived from this study: PubMed 22525956Frazier 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.
Derived from this study: PubMed 18794207Sikich 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linmarie Sikich, M.D. study chair

University of North Carolina, Chapel Hill

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00053703, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.