SchizophreniaNCT00221585
The National Danish Schizophrenia Project
An observational study of Schizophrenia, run by University of Copenhagen at 1 site in Denmark.
Trial summary
A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Psychosocial treatment/Psychodynamic treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Oct 1997to Jul 2005
- Phase
- Observational
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (ICD-10, DF 20-29).
- -
Who cannot join
- patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in Danish due to their foreign origins.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Patients were treated with: 1) 'Supportive psychodynamic psychotherapy as a supplement to treatment as usual', 2) an 'Integrated, assertive, psychosocial and educational treatment programme', and 3) 'Treatment as usual'.
Read the detailed description
The study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. Three sub-cohorts with different treatment modalities were designed:
Treatment1: 119 patients were, in addition to TaU, offered SPP, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). Anti-psychotic medication was given in doses based on individual needs; Treatment 2: 139 patients were offered IT, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. McFarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). This project, OPUS, has been described in detail elsewhere
- Conditions
- Schizophrenia
- Being tested
- Psychosocial treatment/Psychodynamic treatment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial treatment/Psychodynamic treatmentBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 1997
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 CopenhagenThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Investigators
- Bent Rosenbaum, DMSci, Study director, Psychiatric Center Glostrup, Dernmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221585
- Sponsor's protocol ID
- 5490-184
- Status last verified
- Jul 1997
- First submitted
- 16 Sep 2005
- Last updated
- 7 Nov 2006
- Results posted
- No
Publications
Rosenbaum B, Valbak K, Harder S, Knudsen P, Koster A, Lajer M, Lindhardt A, Winther G, Petersen L, Jorgensen P, Nordentoft M, Andreasen AH. The Danish National Schizophrenia Project: prospective, comparative longitudinal treatment study of first-episode psychosis. Br J Psychiatry. 2005 May;186:394-9. doi: 10.1192/bjp.186.5.394.
PubMed 15863743
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Danish Schizophrenia Project
- ClinicalTrials.gov ID
- NCT00221585
- Acronym / sponsor ID
- 5490-184
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Oct 1997
- Study completion
- Jul 2005
- First posted
- 22 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.
A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Patients were treated with: 1) 'Supportive psychodynamic psychotherapy as a supplement to treatment as usual', 2) an 'Integrated, assertive, psychosocial and educational treatment programme', and 3) 'Treatment as usual'.
Detailed description
The study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. Three sub-cohorts with different treatment modalities were designed:
Treatment1: 119 patients were, in addition to TaU, offered SPP, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). Anti-psychotic medication was given in doses based on individual needs; Treatment 2: 139 patients were offered IT, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. McFarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). This project, OPUS, has been described in detail elsewhere
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (ICD-10, DF 20-29).
- -
Key exclusion criteria (1 listed)
- patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in Danish due to their foreign origins.
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 |
|---|---|---|
| Psychosocial treatment/Psychodynamic treatment | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
- Results publication: PubMed 15863743Rosenbaum B, Valbak K, Harder S, Knudsen P, Koster A, Lajer M, Lindhardt A, Winther G, Petersen L, Jorgensen P, Nordentoft M, Andreasen AH. The Danish National Schizophrenia Project: prospective, comparative longitudinal treatment study of first-episode psychosis. Br J Psychiatry. 2005 May;186:394-9. doi: 10.1192/bjp.186.5.394.
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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.
Bent Rosenbaum, DMSci study director
Psychiatric Center Glostrup, Dernmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University of Copenhagen at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Nov 2006. 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 Denmark. 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.
Are results available for this study?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221585, which also lists 1 linked publication.
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 7 Nov 2006.