Trial Outcomes & Findings for Horyzons: Implementation and Integration in Clinical Practice (NCT NCT06002958)
NCT ID: NCT06002958
Last Updated: 2025-09-18
Results Overview
Quantitative data will be collected from providers and peer support specialists (PSSs) at baseline and post-treatment using a structured survey informed by the Consolidated Framework for Implementation Research (CFIR). The survey consists of Likert-style items rated from 1 = "strongly disagree" to 5 = "strongly agree" that capture perceived barriers and facilitators to implementing Horyzons in clinical practice (e.g., "People in our clinic actively seek new ways to improve how we do things"). Items correspond to four subscales based on the CFIR framework: inner setting, outer setting, individual, and process. Subscale scores are calculated by averaging the items within each domain, after reverse scoring when appropriate. Each subscale ranges from 1 to 5, with higher scores indicating more positive perceptions of implementation support for Horyzons (i.e., better outcomes). Descriptive statistics (mean and standard deviation) are reported for each subscale.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
FEP Providers
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
32
|
|
Overall Study
COMPLETED
|
20
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Horyzons: Implementation and Integration in Clinical Practice
Baseline characteristics by cohort
| Measure |
FEP Providers
n=20 Participants
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
n=32 Participants
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.75 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
23.66 years
STANDARD_DEVIATION 4.44 • n=7 Participants
|
29.08 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: This measure only applied to FEP Providers; therefore, data were not collected for FEP Clients.
This qualitative data will be collected post-treatment from providers and PSSs. Individual interviews will discuss the utility and usage of Horyzons within their clinical care in addition to barriers and facilitators on numerous levels (individual, inner setting, and outer setting) of its implementation within their clinic. Feedback will be analyzed using grounded theory and summarized to include common themes regarding implementation, barriers, and enablers within the clinical setting and ideas for future implementation.
Outcome measures
| Measure |
FEP Providers
n=20 Participants
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Platform lacks a true mobile app experience with notifications and updated design
|
7 Participants
|
—
|
|
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Viewed Horyzons as a way to combat loneliness and a safe space to socially engage with peers
|
12 Participants
|
—
|
|
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Flexible/accessible resource that can be used anywhere and anytime
|
10 Participants
|
—
|
|
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Therapy content that appealed to clients (e.g., psychoed and mindfulness exercises)
|
10 Participants
|
—
|
|
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Staff turnover and significant demands on clinicians' time made prioritizing Horyzons challenging
|
10 Participants
|
—
|
|
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
Lacked team integration; often viewed peer support and/or Horyzons as 'separate'
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: This measure only applied to FEP Providers; therefore, data were not collected for FEP Clients.
Quantitative data will be collected from providers and peer support specialists (PSSs) at baseline and post-treatment using a structured survey informed by the Consolidated Framework for Implementation Research (CFIR). The survey consists of Likert-style items rated from 1 = "strongly disagree" to 5 = "strongly agree" that capture perceived barriers and facilitators to implementing Horyzons in clinical practice (e.g., "People in our clinic actively seek new ways to improve how we do things"). Items correspond to four subscales based on the CFIR framework: inner setting, outer setting, individual, and process. Subscale scores are calculated by averaging the items within each domain, after reverse scoring when appropriate. Each subscale ranges from 1 to 5, with higher scores indicating more positive perceptions of implementation support for Horyzons (i.e., better outcomes). Descriptive statistics (mean and standard deviation) are reported for each subscale.
Outcome measures
| Measure |
FEP Providers
n=20 Participants
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Inner (baseline)
|
3.73 score on a scale
Standard Deviation 0.43
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Inner (post-treatment)
|
3.62 score on a scale
Standard Deviation 0.19
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Outer (baseline)
|
3.83 score on a scale
Standard Deviation 0.70
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Outer (post-treatment)
|
3.84 score on a scale
Standard Deviation 0.54
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Individual (baseline)
|
4.21 score on a scale
Standard Deviation 0.48
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Individual (post-treatment)
|
4.03 score on a scale
Standard Deviation 0.48
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Process (baseline)
|
3.77 score on a scale
Standard Deviation 0.62
|
—
|
|
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Process (post-treatment)
|
3.78 score on a scale
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: This measure only applied to FEP Clients; therefore, data were not collected for FEP Providers.
The UCLA Loneliness scale is a 20-item scale. Answers are on a 4-point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit.
Outcome measures
| Measure |
FEP Providers
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
n=32 Participants
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Mean Change in UCLA Loneliness Scale Score
Baseline to Post-treatment
|
—
|
-0.182 score on a scale
Standard Deviation 9.61
|
|
Mean Change in UCLA Loneliness Scale Score
Baseline to Mid-treatment
|
—
|
-0.101 score on a scale
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: This measure only applied to FEP Clients; therefore, data were not collected for FEP Providers.
The MOS Social Support Survey is a 19-item scale. Answers are on a 5-point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 19 to 95. Higher scores reflect higher feelings of social support (more perceived social support). The mean change from baseline to mid-treatment and baseline to post-treatment will be averaged to get the overall mean for each timepoint. The MOS Social Support Survey is a part of the PhenX Toolkit.
Outcome measures
| Measure |
FEP Providers
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
n=32 Participants
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score
Baseline to Mid-treatment
|
—
|
-0.005 score on a scale
Standard Deviation 11.66
|
|
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score
Baseline to Post-treatment
|
—
|
0.155 score on a scale
Standard Deviation 11.66
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: This measure only applied to FEP Clients; therefore, data were not collected for FEP Providers.
This quantitative data will be collected post-treatment from clients. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with total scores ranging from 11-55 and higher scores reflecting a more positive experience.
Outcome measures
| Measure |
FEP Providers
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
n=32 Participants
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Quantitative Summaries of Participant Experience in Post-Treatment Feedback
|
—
|
41.56 score on a scale
Standard Deviation 7.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, up to Month 9Collection of use of emergency and social services pre-initiation and post-initiation of Horyzons will be assessed to determine change in use of such services.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, up to Month 9Changes in engagement with Horyzons will be passively collected for client participants via the platform. Data evaluated will include number of logins, number of journeys, tracks, and activities completed, and number engagements on the community page.
Outcome measures
Outcome data not reported
Adverse Events
FEP Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FEP Clients
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FEP Providers
n=20 participants at risk
FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial.
|
FEP Clients
n=32 participants at risk
Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
|
|---|---|---|
|
Psychiatric disorders
Inpatient Hospitalization due to Non-Adherence to Medication
|
0.00%
0/20 • From the time of signing informed consent through study completion, a total of approximately 9 months.
|
3.1%
1/32 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 9 months.
|
|
Psychiatric disorders
Inpatient Hospitalization due to Change in Medication Dosage
|
0.00%
0/20 • From the time of signing informed consent through study completion, a total of approximately 9 months.
|
3.1%
1/32 • Number of events 1 • From the time of signing informed consent through study completion, a total of approximately 9 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Kelsey Ludwig, PhD
University of North Carolina at Chapel Hill
Phone: (919) 962-1401
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place