SchizophreniaPhase 2/3NCT01869660
Shared Decision Making for Patients With First-admission Schizophrenia
A Phase 2/3 study testing Shared Decision Making in people with Schizophrenia, run by Yokohama City University at 1 site in Japan.
Trial summary
To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Oct 2015
- Phase
- Phase 2/3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted to an acute care psychiatric ward.
- Diagnosed with schizophrenia (ICD-10 codes: F20-F29)
- Aged 16 to 65 years old at admission
- No prior experience of psychiatric admission (first-admission)
Who cannot join
- Diagnosed with moderate to severe mental retardation
- Diagnosed with organic mental disorders (ICD10 codes: F00-F09)
- Having poor Japanese language skill
- Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.
- Conditions
- Schizophrenia
- Being tested
- Shared Decision Making
- Keywords
- First hospitalization
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision MakingBehavioural
The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making | Experimental | The present SDM intervention is based on principles derived from previous randomized controlled trials of SDMs. SDM meetings comprise at least 4 weekly 20 minutes sessions. Meetings have at least three professionals: a case manager (psychiatrists or nurses), a primary doctor, and a nurse/social worker. The focus of the meeting is to empower patients to discuss their attitudes and preferences toward treatments. Receives: Behavioral: Shared Decision Making |
| Usual Care | No intervention | Patients with no special program about decision making. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)
Measured: Within 7days before the date of discharge
Secondary outcomes (2)
Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10)
Measured: Within 7days before the date of discharge
Treatment continuation as measured by the rate of outpatient attendance during the 30 days
Measured: 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshio Hirayasu, PhD, Study chair, Department of Psychiatry, Yokohama City University School of Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869660
- Sponsor's protocol ID
- SDMS-S
- Status last verified
- Aug 2015
- First submitted
- 27 May 2013
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial. BMC Psychiatry. 2017 Feb 6;17(1):52. doi: 10.1186/s12888-017-1218-1.
PubMed 28166757Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial. BMC Psychiatry. 2014 Apr 14;14:111. doi: 10.1186/1471-244X-14-111.
PubMed 24725910
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01869660
- Acronym / sponsor ID
- SDMS-S
- Conditions
- Schizophrenia
- Keywords
- First hospitalization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yokohama City UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Jun 2013 (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.
To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making | Experimental | Behavioral: Shared Decision MakingThe present SDM intervention is based on principles derived from previous randomized controlled trials of SDMs. SDM meetings comprise at least 4 weekly 20 minutes sessions. Meetings have at least three professionals: a case manager (psychiatrists or nurses), a primary doctor, and a nurse/social worker. The focus of the meeting is to empower patients to discuss their attitudes and preferences toward treatments. |
| Usual Care | No intervention | –Patients with no special program about decision making. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to an acute care psychiatric ward.
- Diagnosed with schizophrenia (ICD-10 codes: F20-F29)
- Aged 16 to 65 years old at admission
- No prior experience of psychiatric admission (first-admission)
Key exclusion criteria (4 listed)
- Diagnosed with moderate to severe mental retardation
- Diagnosed with organic mental disorders (ICD10 codes: F00-F09)
- Having poor Japanese language skill
- Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.
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 |
|---|---|---|
| Shared Decision MakingThe focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments. | Behavioural | Shared Decision Making |
Primary outcome
Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Within 7days before the date of discharge
2 secondary outcomes
Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10)
Time frame: Within 7days before the date of discharge
Treatment continuation as measured by the rate of outpatient attendance during the 30 days
Time frame: 6 months after discharge
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 30 Dec 2015.
- Derived from this study: PubMed 28166757Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Feasibility and efficacy of shared decision making for first-admission schizophrenia: a randomized clinical trial. BMC Psychiatry. 2017 Feb 6;17(1):52. doi: 10.1186/s12888-017-1218-1.
- Derived from this study: PubMed 24725910Ishii M, Okumura Y, Sugiyama N, Hasegawa H, Noda T, Hirayasu Y, Ito H. Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial. BMC Psychiatry. 2014 Apr 14;14:111. doi: 10.1186/1471-244X-14-111.
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
Yoshio Hirayasu, PhD study chair
Department of Psychiatry, Yokohama City University School of Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Shared Decision Making in people with Schizophrenia, run by Yokohama City University at 1 site in Japan.
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 4 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 30 Dec 2015. 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 Japan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8) (time frame: Within 7days before the date of discharge). 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 NCT01869660, which also lists 2 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 30 Dec 2015.