Diabetes MellitusTTIMNCT01410357
Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
A study testing Targeted Training in Illness Management (TTIM) in people with Diabetes Mellitus and Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Bipolar Disorder, Depression
- What is being tested?
- Targeted Training in Illness Management (TTIM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
- Have DM based upon either previous diagnosis or laboratory values
- Be ≥ 18 years of age
- Be able to communicate in English
- Be able to provide written, informed consent to participation.
Who cannot join
- Actively suicidal/homicidal
- Unable to be rated on study rating scales
- Demented
- Pregnant
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.
Read the detailed description
This project will test a novel intervention, Targeted Training in Illness Management (TTIM), intended to improve both serious mental illness (SMI) and diabetes mellitus (DM) self-management in 100 individuals with SMI-DM vs. 100 individuals with SMI-DM receiving treatment as usual (TAU). The intervention will be conducted in a safety-net health system primary care setting and will be conducted as a randomized controlled trial (RCT). The primary effects of TTIM will be assessed with respect to SMI symptoms, Functional Status/Role Impairment, General Health Status, and DM outcomes. Secondary outcomes include adherence to psychotropic and DM medication, and engagement in healthy behaviors.
This assessment will include quantitative assessment of facilitators/barriers targeted by the proposed intervention as well as a supplemental qualitative assessment. The qualitative assessments will include input from patients and interventionists. Specific aims for the qualitative analysis are to validate findings from the RCT, expand understanding of "key active ingredients" of TTIM, and provide information to inform future studies on individuals with SMI and related medical conditions.
- Being tested
- Targeted Training in Illness Management (TTIM)
- Keywords
- serious mental illness, diabetes
- Medical subject headings
- Diabetes Mellitus, Bipolar Disorder, Depression, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Training in Illness Management (TTIM)Behavioural
This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Training in Illness Management (TTIM) | Experimental | Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers. Receives: Behavioral: Targeted Training in Illness Management (TTIM) |
| Treatment As Usual (TAU) | No intervention | Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS) at 60 Weeks
The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.
Measured: 60 weeks
Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks
The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.
Measured: 60 weeks
Clinical Global Impression (CGI) at 60 Weeks
The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.
Measured: 60 weeks
Global Assessment of Functioning (GAF) at 60 Weeks
The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.
Measured: 60 weeks
Sheehan Disability Scale (SDS) at 60 Weeks
The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.
Measured: 60 weeks
SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
Measured: 60 weeks
Glycosylated Hemoglobin (HbA1c) at 60 Weeks
Measured: 60 weeks
Systolic Blood Pressure at 60 Weeks
Measured: 60 weeks
Body Mass Index (BMI) at 60 Weeks
Measured: 60 weeks
SF-36 Health Survey at 60 Weeks; Physical Health Component
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
Measured: 60 weeks
Secondary outcomes (8)
Tablets Routine Questionnaire (TRQ) at 60 Weeks
The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications.
Measured: 60 weeks
Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50.
Measured: 60 weeks
Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks
The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment.
Measured: 60 weeks
Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Measured: 60 weeks
Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Measured: 60 weeks
Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Measured: 60 weeks
Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Measured: 60 weeks
Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks
The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness.
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2015
- Study completionJul 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MetroHealth Medical Center
- Responsible party
- Principal investigator, Martha Sajatovic, MD, Case Western Reserve University
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve UniversityNeal V Dawson, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410357
- Sponsor's protocol ID
- R01MH085665
- Other IDs
- R01MH085665
- Acronym
- TTIM
- Status last verified
- Oct 2017
- First submitted
- 29 Jul 2011
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators will make deidentified data available to other qualified investigators in the research community. Data will remain under control of the PIs of the research study at CWRU. Copies of electronic data files accompanied by data documentation (metadata) will be shared. Qualified investigators may contact the PIs for information on how to request data. Investigators will be required (at minimum) to provide 1) the names and qualifications of all individuals who will have any access to primary data files; 2) a research proposal detailing how the data will be used; 3) a statement that the investigators will a) not further share the primary data with third parties, b) protect the privacy of subjects, c) provide a means to protect the confidentiality of the data; and 4) a data transfer/use agreement with CWRU. Only data necessary to meet the goals of the investigators' research proposal will be provided to limit the risk of identifying individual research subjects.
Publications
Sajatovic M, Howland M, Gunzler D, Kanuch SW, Cassidy KA, McCormick R, Bauer MS, Scheidemantel T, Thomas C, Blixen C, Dawson NV. Race analysis in an African American sample with serious mental illness and comorbid diabetes. Psychiatr Rehabil J. 2018 Sep;41(3):246-252. doi: 10.1037/prj0000314.
PubMed 30160510Aftab A, Bhat C, Gunzler D, Cassidy K, Thomas C, McCormick R, Dawson NV, Sajatovic M. Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial. Int J Psychiatry Med. 2018 May;53(3):126-140. doi: 10.1177/0091217417749795. Epub 2017 Dec 27.
PubMed 29280685
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
- ClinicalTrials.gov ID
- NCT01410357
- Acronym / sponsor ID
- TTIM / R01MH085665
- Keywords
- serious mental illness, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MetroHealth Medical Center
- Study start
- Jul 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.
Detailed description
This project will test a novel intervention, Targeted Training in Illness Management (TTIM), intended to improve both serious mental illness (SMI) and diabetes mellitus (DM) self-management in 100 individuals with SMI-DM vs. 100 individuals with SMI-DM receiving treatment as usual (TAU). The intervention will be conducted in a safety-net health system primary care setting and will be conducted as a randomized controlled trial (RCT). The primary effects of TTIM will be assessed with respect to SMI symptoms, Functional Status/Role Impairment, General Health Status, and DM outcomes. Secondary outcomes include adherence to psychotropic and DM medication, and engagement in healthy behaviors.
This assessment will include quantitative assessment of facilitators/barriers targeted by the proposed intervention as well as a supplemental qualitative assessment. The qualitative assessments will include input from patients and interventionists. Specific aims for the qualitative analysis are to validate findings from the RCT, expand understanding of "key active ingredients" of TTIM, and provide information to inform future studies on individuals with SMI and related medical conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Training in Illness Management (TTIM) | Experimental | Behavioral: Targeted Training in Illness Management (TTIM)Participants in this arm will receive the TTIM intervention as well as receiving regular treatment for their DM and SMI from their normal medical and mental health care providers. |
| Treatment As Usual (TAU) | No intervention | –Participants in this arm will continue to receive Treatment as Usual from their usual medical and mental health care providers. They will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression
- Have DM based upon either previous diagnosis or laboratory values
- Be ≥ 18 years of age
- Be able to communicate in English
- Be able to provide written, informed consent to participation.
Key exclusion criteria (5 listed)
- Actively suicidal/homicidal
- Unable to be rated on study rating scales
- Demented
- Pregnant
- Unable to provide 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 |
|---|---|---|
| Targeted Training in Illness Management (TTIM)This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management. | Behavioural | Targeted Training in Illness Management (TTIM) |
Primary outcome
Brief Psychiatric Rating Scale (BPRS) at 60 Weeks
Time frame: 60 weeks
The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.
Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks
Time frame: 60 weeks
The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.
Clinical Global Impression (CGI) at 60 Weeks
Time frame: 60 weeks
The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.
Global Assessment of Functioning (GAF) at 60 Weeks
Time frame: 60 weeks
The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.
Sheehan Disability Scale (SDS) at 60 Weeks
Time frame: 60 weeks
The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.
SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component
Time frame: 60 weeks
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
Glycosylated Hemoglobin (HbA1c) at 60 Weeks
Time frame: 60 weeks
Systolic Blood Pressure at 60 Weeks
Time frame: 60 weeks
Body Mass Index (BMI) at 60 Weeks
Time frame: 60 weeks
SF-36 Health Survey at 60 Weeks; Physical Health Component
Time frame: 60 weeks
The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.
8 secondary outcomes
Tablets Routine Questionnaire (TRQ) at 60 Weeks
Time frame: 60 weeks
Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks
Time frame: 60 weeks
Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks
Time frame: 60 weeks
Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks
Time frame: 60 weeks
Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks
Time frame: 60 weeks
Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks
Time frame: 60 weeks
Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks
Time frame: 60 weeks
Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks
Time frame: 60 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30160510Sajatovic M, Howland M, Gunzler D, Kanuch SW, Cassidy KA, McCormick R, Bauer MS, Scheidemantel T, Thomas C, Blixen C, Dawson NV. Race analysis in an African American sample with serious mental illness and comorbid diabetes. Psychiatr Rehabil J. 2018 Sep;41(3):246-252. doi: 10.1037/prj0000314.
- Derived from this study: PubMed 29280685Aftab A, Bhat C, Gunzler D, Cassidy K, Thomas C, McCormick R, Dawson NV, Sajatovic M. Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial. Int J Psychiatry Med. 2018 May;53(3):126-140. doi: 10.1177/0091217417749795. Epub 2017 Dec 27.
- Individual participant dataSharing planned: Yes. The investigators will make deidentified data available to other qualified investigators in the research community. Data will remain under control of the PIs of the research study at CWRU. Copies of electronic data files accompanied by data documentation (metadata) will be shared. Qualified investigators may contact the PIs for information on how to request data. Investigators will be required (at minimum) to provide 1) the names and qualifications of all individuals who will have any access to primary data files; 2) a research proposal detailing how the data will be used; 3) a statement that the investigators will a) not further share the primary data with third parties, b) protect the privacy of subjects, c) provide a means to protect the confidentiality of the data; and 4) a data transfer/use agreement with CWRU. Only data necessary to meet the goals of the investigators' research proposal will be provided to limit the risk of identifying individual research subjects.
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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.
Martha Sajatovic, MD principal investigator
Case Western Reserve University
Neal V Dawson, MD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Training in Illness Management (TTIM) in people with Diabetes Mellitus and Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
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 5 inclusion and 5 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 4 Oct 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2017). 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?
Brief Psychiatric Rating Scale (BPRS) at 60 Weeks (time frame: 60 weeks). The study lists 10 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 NCT01410357, 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 4 Oct 2017.