Suicidal IdeationAIMNCT03080168
The "AIM Study": Investigating Whether Actigraphy and Ideation Measures Can Promote Patient Safety
An observational study of Suicidal Ideation and Suicidal Behavior, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions. This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicidal Behavior, Mental Health Symptoms
- What is being tested?
- Actigraph
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2017to 1 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: US Veteran inpatients hospitalized for suicidal ideation, suicidal behavior, or alcohol detoxification
Who may be able to join
- age 18 years or older and endorsing either suicidal ideation upon admission or within the last 7 days, or endorsing (or otherwise documented) suicidal behavior within the past 14 days before admission; OR
- age 18 years or older and undergoing alcohol detoxification (including patients who qualify under #1 and are undergoing alcohol detoxification).
Who cannot join
- presence of a primary psychotic disorder [schizophrenia, schizoaffective disorder, psychosis not otherwise specified, and other psychoses] diagnosis on admission; or major depressive disorder with psychosis, or current hallucinations or ideas of reference, endorsing current psychotic thinking on the Psychosis Screen measure
- presence of a flag specifying a history of disruptive or violent behavior, or, if found during review of elements of the patient's chart prior to study enrollment, indication of a history of violent behavior towards staff, caregivers, or other patients in the patient's record, or if discussion with hospital staff indicates the potential participant's mental status is unstable enough or hostile enough to raise concerns about assaultive behavior
- Prisoner (of federal, state, or local authorities)
- Currently admitted to 78G under an involuntary commitment (e.g., "Section 12"). Specifically, no patients will be enrolled as participants who were committed to the inpatient unit involuntarily who has not chosen voluntarily to change their status to that of a voluntarily admitted patient (ie., signed a "Conditional Voluntary" form)
- Interviewer or Hospital staff-suspected or chart-documented presence of mental retardation (IQ <70) or other DSM-IV organic mental disorder (e.g., including Alzheimer's dementia)
- acute alcohol or drug intoxication or any delirium
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- receiving alcohol detoxification treatment [for Primary Analysis]
- women who are pregnant
- patients undergoing detoxification for opiates
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Official title: Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker
This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions.
This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts.
In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.
Read the detailed description
As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment was been placed on temporary administrative hold as of 3 17 2020. As the pandemic has continued, we have reviewed our data and decided to close the study to enrollment and proceed to our analyses of findings.
RESEARCH DESIGN: A prospective cohort study of Veterans will be conducted to determine if the previously-identified specific actigraphy-based measurements highly associated with suicidal ideation in non-Veterans will predict suicidal ideation, suicidal behavior, and/or rehospitalization in Veterans.
METHODS: An analysis of Veterans admitted to the Bedford, Massachusetts VAMC acute psychiatry unit will be conducted. The primary analysis will focus upon Veterans with current suicidal ideation or recent suicidal behavior (SI/SB) who do not have a primary psychotic disorder, Alzheimer's, or Parkinson's disease, and who are not undergoing alcohol detoxification. A separate analysis will be conducted of patients undergoing alcohol detoxification, half with SI/SB and half without SI/SB. Participants will wear a small, unobtrusive, wristwatch-like actigraph on their nondominant wrist, and complete self-rated and clinician-rated assessments of suicidal ideation, as well as self-rated assessments of the severity of other psychiatric symptoms. A Resiliency Index (RI) will be calculated using nonlinear dynamic analysis of the amplitude of movements over time frames from 6 minutes - 2 hours. These time frames are the periods for which a clear structure to the movement data is evident, with patients with suicidal ideation showing less variation in amplitude than patients without suicidal ideation. If medications given for alcohol detoxification are determined to not interfere with the RI, then a secondary analysis will examine the entire sample of Veterans. One Aim will focus upon determining whether the original Resiliency Index or alternative movement data indices, such as one based on the change in the movement data over the hospitalization, predicts the presence and severity of suicidal ideation among Veteran inpatients. This aim will also examine the sensitivity and specificity of the RI for detecting the presence of any suicidal ideation, and of substantial suicidal ideation. (In non-Veterans, the RI showed a sensitivity of 72% and a specificity of 100% for detecting any suicidal ideation, and 86% and 88%, respectively, for detecting substantial ideation). In addition, the investigators may determine whether the RI predicts subsequent suicidal behavior or rehospitalization over different time periods within the original 12 month followup period, alone or combined with data about symptom severity, past history, and the present hospitalization.
- Conditions
- Suicidal Ideation, Suicidal Behavior, Mental Health Symptoms, Mental Health Hospitalizations
- Being tested
- Actigraph
- Keywords
- suicidal ideation, suicidal behavior, Veterans, inpatients, Actigraphy, implicit associations, risk factors
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphDevice
This is NOT an intervention but a monitoring device. All participants will wear an Actigraph for the duration of their inpatient stay, as well as complete paper and computer assessments.
| Study group | Role | What they receive |
|---|---|---|
| Actigraph | All participants will wear an Actigraph (monitoring device) for the duration of their inpatient stay.
NOTE: In clarification, for both this section and Section 4, this devices is an FDA-regulated monitoring device, but NOT an Intervention in this study. Receives: Device: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
POST DISCHARGE FOLLOW-UP (COMPOSITE): CSSRS Suicidal Behaviors (self-report), Rehospitalization with Suicidal Ideation (self-report), combined with chart data re Suicidal Behavior and Rehospitalization with Suicidal Ideation
The investigators will call some participants who are not undergoing alcohol detoxification and administer the Columbia-Suicide Severity Rating Scale to determine occurrence of all suicidal behavior (actual, interrupted, aborted, and preparatory), ask them to also self-report rehospitalization with suicidal ideation (SI), and use VA chart data as another source of information about suicidal behavior and rehospitalization.
For those patients who we reach by phone we will use both their self-report and the information from chart review to inform this outcome, and from those patients not undergoing analysis who we don't reach, or those who are in participant groups not receiving phone calls (the participants undergoing alcohol detoxification).
The data will then be reconciled and combined into a measure of Suicidal Behavior or rehospitalization with suicidal ideation over the 12 months since discharge.
Measured: 12 months since discharge from index hospitalization
INPATIENT: Sheehan STS scale
Association of Actigraph measurements with Sheehan STS Scale
Measured: Last 24 hours up to assessment
Secondary outcomes (10)
INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis]
Participants rank the Severity and Duration of their suicidal thinking on 0-10 scales each day, This outcome will look at the distribution of the interaction between the scores (e.g., multiplicative/multiplication of scores) and determine whether that simple interaction/combination will be used, log or otherwise transformed, and/or more weighting given to duration than severity, etc. This determination will be made on the spread of this data, not any information about how it correlates with actigraphy or other data gathered. This is being designated a secondary outcome simply because how the measure will be determined is not yet specified, but it is expected that this composite measure will likely have a stronger association with actigraphy and other RFs (risk factors)/predictors than simply the severity of suicidal ideation, one of the co-primary outcomes.
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days)
POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]
The investigators will use the data gathered from the CSSRS from phone interviews and chart review to determine the occurrence of Actual Suicidal Behavior in the 12 months since discharge. We will use both sources of information to assess those patients who are reached by phone and the chart review alone for those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).
Measured: 12 months (12 months since discharge from index hospitalization)
POST-DISCHARGE FOLLOW-UP: All Suicidal Behavior plus Rehospitalization plus Severity of Worst Suicidal Ideation (Some Intent or Some Intent or Plan) [Main Secondary]
The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI, as well as determine information from the chart about the occurrence of these outcomes, both for patients who are reached by phone and those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).
Measured: 12 months since Discharge
INPATIENT: Severity of Suicidal Ideation
Daily rankings of Severity of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days [It is anticipated most subjects will provide from 2-7 days of data)
INPATIENT: Duration of Suicidal Ideation (Thinking Diary)
Daily rankings of Duration of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Duration of Suicidal Ideation (Hours/minutes)
Daily rankings of Duration of Suicidal Ideation, from the Sheehan Tracking Scale, in hours and minutes.
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day
Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan).
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Wish to be Dead
Daily rankings of Wish to be Dead, from the Thinking Diary, on a 0-10 scale. [This was the outcome used in the previous actigraphy study].
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items
Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan) combined with the items/scores in the 2nd half of the suicidal ideation assessment (frequency, controllability). Investigators will use chart and interview information for patients who can be reached by phone and interview information for those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls). Exact procedure for combining (e.g. simple addition) to be determined, possibly in consultation with Columbia scale staff.
Measured: Duration of Inpatient Stay (Daily Measures, up to 365 days)
Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale)
We have created our own 0-10 scale of the highest intensity of suicidal thinking a participant experienced in the 12 months post-discharge. This will be used for some of the secondary analyses of outcomes 12 months after discharge. While it is not validated, it has the advantage that, as opposed to any Yes/No events (rehospitalization, experiencing of a certain severity of suicidal thinking), that every study participant will have a value on this particular scale.
Measured: 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start21 Feb 2017
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric G. Smith, MD PhD MPH, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080168
- Sponsor's protocol ID
- MHBA-017-15S
- Other IDs
- 1I01CX001424-01
- Acronym
- AIM
- Status last verified
- Apr 2021
- First submitted
- 21 Feb 2017
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker
- ClinicalTrials.gov ID
- NCT03080168
- Acronym / sponsor ID
- AIM / MHBA-017-15S
- Conditions
- Suicidal Ideation, Suicidal Behavior, Mental Health Symptoms, Mental Health Hospitalizations
- Keywords
- suicidal ideation, suicidal behavior, Veterans, inpatients, Actigraphy, implicit associations, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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.
This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions.
This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts.
In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.
Detailed description
As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment was been placed on temporary administrative hold as of 3 17 2020. As the pandemic has continued, we have reviewed our data and decided to close the study to enrollment and proceed to our analyses of findings.
RESEARCH DESIGN: A prospective cohort study of Veterans will be conducted to determine if the previously-identified specific actigraphy-based measurements highly associated with suicidal ideation in non-Veterans will predict suicidal ideation, suicidal behavior, and/or rehospitalization in Veterans.
METHODS: An analysis of Veterans admitted to the Bedford, Massachusetts VAMC acute psychiatry unit will be conducted. The primary analysis will focus upon Veterans with current suicidal ideation or recent suicidal behavior (SI/SB) who do not have a primary psychotic disorder, Alzheimer's, or Parkinson's disease, and who are not undergoing alcohol detoxification. A separate analysis will be conducted of patients undergoing alcohol detoxification, half with SI/SB and half without SI/SB. Participants will wear a small, unobtrusive, wristwatch-like actigraph on their nondominant wrist, and complete self-rated and clinician-rated assessments of suicidal ideation, as well as self-rated assessments of the severity of other psychiatric symptoms. A Resiliency Index (RI) will be calculated using nonlinear dynamic analysis of the amplitude of movements over time frames from 6 minutes - 2 hours. These time frames are the periods for which a clear structure to the movement data is evident, with patients with suicidal ideation showing less variation in amplitude than patients without suicidal ideation. If medications given for alcohol detoxification are determined to not interfere with the RI, then a secondary analysis will examine the entire sample of Veterans. One Aim will focus upon determining whether the original Resiliency Index or alternative movement data indices, such as one based on the change in the movement data over the hospitalization, predicts the presence and severity of suicidal ideation among Veteran inpatients. This aim will also examine the sensitivity and specificity of the RI for detecting the presence of any suicidal ideation, and of substantial suicidal ideation. (In non-Veterans, the RI showed a sensitivity of 72% and a specificity of 100% for detecting any suicidal ideation, and 86% and 88%, respectively, for detecting substantial ideation). In addition, the investigators may determine whether the RI predicts subsequent suicidal behavior or rehospitalization over different time periods within the original 12 month followup period, alone or combined with data about symptom severity, past history, and the present hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actigraph | – | Device: ActigraphAll participants will wear an Actigraph (monitoring device) for the duration of their inpatient stay. NOTE: In clarification, for both this section and Section 4, this devices is an FDA-regulated monitoring device, but NOT an Intervention in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- US Veteran inpatients hospitalized for suicidal ideation, suicidal behavior, or alcohol detoxification
Key inclusion criteria (2 listed)
- age 18 years or older and endorsing either suicidal ideation upon admission or within the last 7 days, or endorsing (or otherwise documented) suicidal behavior within the past 14 days before admission; OR
- age 18 years or older and undergoing alcohol detoxification (including patients who qualify under #1 and are undergoing alcohol detoxification).
Key exclusion criteria (9 listed)
- presence of a primary psychotic disorder [schizophrenia, schizoaffective disorder, psychosis not otherwise specified, and other psychoses] diagnosis on admission; or major depressive disorder with psychosis, or current hallucinations or ideas of reference, endorsing current psychotic thinking on the Psychosis Screen measure
- presence of a flag specifying a history of disruptive or violent behavior, or, if found during review of elements of the patient's chart prior to study enrollment, indication of a history of violent behavior towards staff, caregivers, or other patients in the patient's record, or if discussion with hospital staff indicates the potential participant's mental status is unstable enough or hostile enough to raise concerns about assaultive behavior
- Prisoner (of federal, state, or local authorities)
- Currently admitted to 78G under an involuntary commitment (e.g., "Section 12"). Specifically, no patients will be enrolled as participants who were committed to the inpatient unit involuntarily who has not chosen voluntarily to change their status to that of a voluntarily admitted patient (ie., signed a "Conditional Voluntary" form)
- Interviewer or Hospital staff-suspected or chart-documented presence of mental retardation (IQ <70) or other DSM-IV organic mental disorder (e.g., including Alzheimer's dementia)
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 |
|---|---|---|
| ActigraphThis is NOT an intervention but a monitoring device. All participants will wear an Actigraph for the duration of their inpatient stay, as well as complete paper and computer assessments. | Device | Actigraph |
Primary outcome
POST DISCHARGE FOLLOW-UP (COMPOSITE): CSSRS Suicidal Behaviors (self-report), Rehospitalization with Suicidal Ideation (self-report), combined with chart data re Suicidal Behavior and Rehospitalization with Suicidal Ideation
Time frame: 12 months since discharge from index hospitalization
The investigators will call some participants who are not undergoing alcohol detoxification and administer the Columbia-Suicide Severity Rating Scale to determine occurrence of all suicidal behavior (actual, interrupted, aborted, and preparatory), ask them to also self-report rehospitalization with suicidal ideation (SI), and use VA chart data as another source of information about suicidal behavior and rehospitalization. For those patients who we reach by phone we will use both their self-report and the information from chart review to inform this outcome, and from those patients not undergoing analysis who we don't reach, or those who are in participant groups not receiving phone calls (the participants undergoing alcohol detoxification). The data will then be reconciled and combined into a measure of Suicidal Behavior or rehospitalization with suicidal ideation over the 12 months since discharge.
INPATIENT: Sheehan STS scale
Time frame: Last 24 hours up to assessment
Association of Actigraph measurements with Sheehan STS Scale
10 secondary outcomes
INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis]
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]
Time frame: 12 months (12 months since discharge from index hospitalization)
POST-DISCHARGE FOLLOW-UP: All Suicidal Behavior plus Rehospitalization plus Severity of Worst Suicidal Ideation (Some Intent or Some Intent or Plan) [Main Secondary]
Time frame: 12 months since Discharge
INPATIENT: Severity of Suicidal Ideation
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days [It is anticipated most subjects will provide from 2-7 days of data)
INPATIENT: Duration of Suicidal Ideation (Thinking Diary)
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Duration of Suicidal Ideation (Hours/minutes)
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Wish to be Dead
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items
Time frame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale)
Time frame: 12 months post-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 5 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Eric G. Smith, MD PhD MPH principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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 Suicidal Ideation and Suicidal Behavior, run by VA Office of Research and Development 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 2 inclusion and 9 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 5 Apr 2021. 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?
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?
POST DISCHARGE FOLLOW-UP (COMPOSITE): CSSRS Suicidal Behaviors (self-report), Rehospitalization with Suicidal Ideation (self-report), combined with chart data re Suicidal Behavior and Rehospitalization with Suicidal Ideation (time frame: 12 months since discharge from index hospitalization). The study lists 2 primary outcomes in all. 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 5 Apr 2021.