SchizophreniaPhase 3NCT00184509
Continued Early Intervention for Recent-onset Schizophrenia
A Phase 3 study testing integrated psychosocial treatment (behavior) in people with Schizophrenia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- integrated psychosocial treatment (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Feb 1993to May 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- first-episode schizophrenia
Who cannot join
- acute psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continued Early Intervention for Recent-onset Schizophrenia. A Randomized Controlled Study.
The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment.
Read the detailed description
Early intervention for schizophrenia has spawned considerable enthusiasm among clinicians without solid research evidence to suport its benefits and costs. The present study is a random-controlled study of integrated biomedical and psychosocial treatment on a population of recent-onset cases.
Comparison(s): 50 consecutive referrals with schizophrenic disorders of less than two years duration were allocated randomly to a comprehensive model of integrated treatment or standard care for two years. Main outcome measures was psychopathology, psychosocial functioning and hospital admissions.
- Conditions
- Schizophrenia
- Being tested
- integrated psychosocial treatment (behavior)
- Keywords
- schizophrenia, psychosocial treatment, outcome
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated psychosocial treatment (behavior)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalizations and psychotic relapse at two years
Secondary outcomes (1)
Psychopathology, psychosocial changes, functioning, antipsychotic medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 1993
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Investigators
- K. Gunnar Gøtestam, MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184509
- Sponsor's protocol ID
- SHDIR-1992-1995; NFR-1997-1999
- Status last verified
- Jan 2017
- First submitted
- 15 Sep 2005
- Last updated
- 26 Jan 2017
- Results posted
- No
Publications
Sigrunarson V, Grawe RW, Lydersen S, Morken G. Predictors of long term use of psychiatric services of patients with recent-onset schizophrenia: 12 years follow-up. BMC Psychiatry. 2017 Jan 14;17(1):18. doi: 10.1186/s12888-016-1186-x.
PubMed 28088223Sigrunarson V, Grawe RW, Morken G. Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial. BMC Psychiatry. 2013 Jul 30;13:200. doi: 10.1186/1471-244X-13-200.
PubMed 23898805Morken G, Widen JH, Grawe RW. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry. 2008 Apr 30;8:32. doi: 10.1186/1471-244X-8-32.
PubMed 18447935Morken G, Grawe RW, Widen JH. Effects of integrated treatment on antipsychotic medication adherence in a randomized trial in recent-onset schizophrenia. J Clin Psychiatry. 2007 Apr;68(4):566-71. doi: 10.4088/jcp.v68n0409.
PubMed 17474812
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Early Intervention for Recent-onset Schizophrenia. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00184509
- Acronym / sponsor ID
- SHDIR-1992-1995; NFR-1997-1999
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, psychosocial treatment, outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Feb 1993
- Study completion
- May 1998
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment.
Detailed description
Early intervention for schizophrenia has spawned considerable enthusiasm among clinicians without solid research evidence to suport its benefits and costs. The present study is a random-controlled study of integrated biomedical and psychosocial treatment on a population of recent-onset cases.
Comparison(s): 50 consecutive referrals with schizophrenic disorders of less than two years duration were allocated randomly to a comprehensive model of integrated treatment or standard care for two years. Main outcome measures was psychopathology, psychosocial functioning and hospital admissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first-episode schizophrenia
Key exclusion criteria (1 listed)
- acute psychosis
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 |
|---|---|---|
| integrated psychosocial treatment (behavior) | Behavioural | – |
Primary outcome
Rehospitalizations and psychotic relapse at two years
1 secondary outcome
Psychopathology, psychosocial changes, functioning, antipsychotic medication
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 28088223Sigrunarson V, Grawe RW, Lydersen S, Morken G. Predictors of long term use of psychiatric services of patients with recent-onset schizophrenia: 12 years follow-up. BMC Psychiatry. 2017 Jan 14;17(1):18. doi: 10.1186/s12888-016-1186-x.
- Derived from this study: PubMed 23898805Sigrunarson V, Grawe RW, Morken G. Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial. BMC Psychiatry. 2013 Jul 30;13:200. doi: 10.1186/1471-244X-13-200.
- Derived from this study: PubMed 18447935Morken G, Widen JH, Grawe RW. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry. 2008 Apr 30;8:32. doi: 10.1186/1471-244X-8-32.
- Derived from this study: PubMed 17474812Morken G, Grawe RW, Widen JH. Effects of integrated treatment on antipsychotic medication adherence in a randomized trial in recent-onset schizophrenia. J Clin Psychiatry. 2007 Apr;68(4):566-71. doi: 10.4088/jcp.v68n0409.
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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.
K. Gunnar Gøtestam, MD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing integrated psychosocial treatment (behavior) in people with Schizophrenia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Rehospitalizations and psychotic relapse at two years. 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 NCT00184509, which also lists 4 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 Jan 2017.