Mood DisordersNCT02453438
Mood Patient Powered Research Network (MoodNetwork)
An observational study of Mood Disorders and Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disorders, Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- Patient Reported Outcomes
- How many people
- 5,716 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2019
- How long will I take part?
- 3 Years
- 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: English speaking individuals over 18 years of age who self-identify as having a mood disorder.
Who may be able to join
- English speaking
- Valid email address
- Self-identify as having a mood disorder
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Bipolar Clinic and Research Program
Boston, Massachusetts, 02134
About this study
The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to patients and other stakeholders. A robust data infrastructure will be built that, in phase one, allows participants to contribute data, including those from participant questionnaires, visualize their own health information in intuitive and helpful ways, and share their aggregated de-identified health information within and outside of the Network.
- Being tested
- Patient Reported Outcomes
- Medical subject headings
- Mood Disorders, Bipolar Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported OutcomesOther
Patient reported outcomes will be collected using a variety of questionnaires that assess mood symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Working Group Items Questionnaire
Measured: average of 3 years
Composite International Diagnostic Interview Mania Questionnaire
Measured: average of 3 years
Mini International Neuropsychiatric Interview Depression
Measured: average of 3 years
Quick Inventory of Depressive Symptoms Self Report
Measured: average of 3 years
Altman Self Rated Mania Scale
Measured: average of 3 years
WHO-five well-being index (WHO-5)
Measured: average of 3 years
Depression and Bipolar Support Alliance Wellness Tracker Questionnaire
Measured: average of 3 years
Experience of Care and Health Outcomes Questionnaire
Measured: average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 5,716 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew A. Nierenberg, MD, Massachusetts General Hospital
- Investigators
- Andrew A Nierenberg, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453438
- Sponsor's protocol ID
- 2014P001346
- Status last verified
- Sep 2019
- First submitted
- 5 May 2015
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Patient Powered Research Network (MoodNetwork)
- ClinicalTrials.gov ID
- NCT02453438
- Acronym / sponsor ID
- 2014P001346
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,716 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to patients and other stakeholders. A robust data infrastructure will be built that, in phase one, allows participants to contribute data, including those from participant questionnaires, visualize their own health information in intuitive and helpful ways, and share their aggregated de-identified health information within and outside of the Network.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- English speaking individuals over 18 years of age who self-identify as having a mood disorder.
Key inclusion criteria (3 listed)
- English speaking
- Valid email address
- Self-identify as having a mood disorder
Key exclusion criteria (1 listed)
- Under 18 years of age
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 |
|---|---|---|
| Patient Reported OutcomesPatient reported outcomes will be collected using a variety of questionnaires that assess mood symptoms. | Other | – |
Primary outcome
Patient Reported Outcomes Working Group Items Questionnaire
Time frame: average of 3 years
Composite International Diagnostic Interview Mania Questionnaire
Time frame: average of 3 years
Mini International Neuropsychiatric Interview Depression
Time frame: average of 3 years
Quick Inventory of Depressive Symptoms Self Report
Time frame: average of 3 years
Altman Self Rated Mania Scale
Time frame: average of 3 years
WHO-five well-being index (WHO-5)
Time frame: average of 3 years
Depression and Bipolar Support Alliance Wellness Tracker Questionnaire
Time frame: average of 3 years
Experience of Care and Health Outcomes Questionnaire
Time frame: average of 3 years
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 6 Sep 2019.
Related trials for Mood Disorders
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
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.
Andrew A Nierenberg, M.D. principal investigator
Massachusetts General Hospital
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 Mood Disorders and Bipolar Disorder, run by Massachusetts General Hospital 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 3 inclusion and 1 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 6 Sep 2019. 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?
Patient Reported Outcomes Working Group Items Questionnaire (time frame: average of 3 years). The study lists 8 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 6 Sep 2019.