SchizophreniaNCT00220870
Shared Decision Making for Schizophrenia
A study testing Decision aid in people with Schizophrenia, run by Technical University of Munich at 1 site in Germany.
Trial summary
The impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Aug 2005
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenia (ICD10)
- age 18 - 65 years
- inpatients
Who cannot join
- mental retardation
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Decision Making in the Therapy of Schizophrenia
The impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care.
Read the detailed description
to follow
- Conditions
- Schizophrenia
- Being tested
- Decision aid
- Keywords
- schizophrenia, shared decision making, compliance, maintenance therapy
- Medical subject headings
- Schizophrenia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' compliance
Secondary outcomes (3)
perceived involvement in medical decisions
rehospitalizations
QoL
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 startJan 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Werner Kissling, MD, Study chair, TU München, Psychiatric Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220870
- Sponsor's protocol ID
- 217-43794-5/9
- Other IDs
- 217-43794-5/9
- Status last verified
- Apr 2010
- First submitted
- 15 Sep 2005
- Last updated
- 8 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in the Therapy of Schizophrenia
- ClinicalTrials.gov ID
- NCT00220870
- Acronym / sponsor ID
- 217-43794-5/9
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, shared decision making, compliance, maintenance therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Aug 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.
The impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care.
Detailed description
to follow
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- schizophrenia (ICD10)
- age 18 - 65 years
- inpatients
Key exclusion criteria (2 listed)
- mental retardation
- no informed consent
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 |
|---|---|---|
| Decision aid | Behavioural | – |
Primary outcome
Patients' compliance
3 secondary outcomes
perceived involvement in medical decisions
rehospitalizations
QoL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
- Related InfoLink provided by the sponsor.
Related trials for Schizophrenia
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Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
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Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
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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.
Werner Kissling, MD study chair
TU München, Psychiatric Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Schizophrenia, run by Technical University of Munich at 1 site in Germany.
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 3 inclusion and 2 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 8 Apr 2010. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients' compliance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2010.