Bipolar DisorderPhase 1/2NCT02811133
Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
A Phase 1/2 study testing Inositol in people with Bipolar Disorder and Anxiety Disorders, run by Ronald M. Glick, MD at 1 site in United States.
Trial summary
This is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Bipolar Disorder, Anxiety Disorders, Anxiety
- What is being tested?
- Inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2023to 4 Oct 2023
- Phase
- Phase 1/2
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Evidence in the medical record confirming the DSM-V diagnosis of bipolar disorder. If this documentation is not in the record, then the appropriate sections of K-SADS will be administered to confirm the diagnosis.
- Evidence in the medical record confirming the DSM-V diagnosis of anxiety disorder including; separation anxiety disorder, generalized anxiety disorder, and/or social phobia. If this documentation is not present or is more than 2 years old, then the appropriate section of the K-SADS will be administered to confirm diagnosis.
- At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
- On a stable dose of psychotropic medications for at least one month, with no major changes projected.
Who cannot join
- Presence of prominent diarrhea.
- Diagnosis of diabetes mellitus.
- Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
- Weight less than 20 kg.
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Child and Adolescent Bipolar Services-WPIC Bellefield
Pittsburgh, Pennsylvania, 15213
About this study
This is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response.
Read the detailed description
Anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefits for bipolar depression in adults. This is an open multi-case control study. The investigators will enroll 20 children and adolescents ages 8-17 treated at the Child and Adolescent Bipolar Services (CABS) at Western Psychiatric Institute and Clinic. Participants' involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. Primary outcomes will include standard measures of mood and anxiety. Also, physiologic measures including body mass index and bedside glucose will be followed.
- Conditions
- Bipolar Disorder, Anxiety Disorders, Anxiety
- Being tested
- Inositol
- Keywords
- inositol
- Medical subject headings
- Bipolar Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InositolDrug
Also called Myoinositol
Subjects will receive inositol
| Study group | Role | What they receive |
|---|---|---|
| Inositol | Experimental | Subjects will receive inositol Receives: Drug: Inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
This assessment rates the clinician's view of the patient's anxiety severity prior to and after initiating myo-inositol. Scores range from 0-7. Higher scores mean worse outcome.
Measured: Weeks 1-12
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S).
This scale is a parent and child report tool that evaluates participants' anxiety and assesses if there has been a decline in clinical status. Answer options are "0-None", "1-Mild", "2-Moderate", and "3-Severe" and describe symptoms of anxiety. Higher scores mean worse outcome.
Measured: Weeks 1-12
To measure the tolerability of myo-inositol, the number of participants who are able to remain on myo-inositol for the full treatment period (10-12 weeks) will be measured.
At study completion, the number of participants who remained on myo-inositol for the full 10-12 weeks will be counted.
Measured: Weeks 1-14
To measure the tolerability of myo-inositol, the number of participants able to remain on the full dosage of myo-inositol for the full treatment period (10-12 weeks) will be measured.
Participants will be titrated up to the full dose of myo-inositol by Week 3 and will remain on the full dose for 6 weeks unless they cannot tolerate the dose. At study completion, the number of participants who remained on the full-dose of myo-inositol for the full 10-12 weeks will be counted.
Measured: Weeks 3-8
To measure the safety and tolerability of myo-inositol, a change from baseline on the Physical Symptom Checklist (Side Effect Rating Scale) will be measured.
This assessment is a parent and child report measure. Its scores range from 0 to 60. Higher scores are indicative of more physical and psychological symptoms and worse outcome.
Measured: Weeks 1-14
To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.
The B-SSRS probes for suicidal thoughts and behavior. The scores for both categories range from 0-5. If participants score greater than 1 on B-SSRS ideation or greater than 0 on B-SSRS behavior, then they cannot be enrolled or remain in the study. Higher scores mean worse outcome.
Measured: Weeks 1-12
To measure the safety of myo-inositol, a fingerstick blood test will be done to measure glucose levels at the first and final study visits.
A glucometer will be used to test the blood glucose levels of participants.
Measured: Week 1 & Week 10-12
To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.
Myo-inositol is dosed by the weight of the participant. To make sure the participant is taking the correct dose, weight will be measured at each study visit. Height will only be measured at Week 1 to calculate BMI. Also, change in weight or BMI will be followed.
Measured: Weeks 1-12
Secondary outcomes (7)
To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.
The Mood and Feelings Questionnaire (MFQ) is a child and parent report questionnaire that measures depressive symptoms in children and young adults. Scores range from 0 to 66. Higher score are indicative of increased depressive symptom severity and worse outcome.
Measured: Weeks 1-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.
This assessment rates the clinician's view of the patient's anxiety improvement after initiating myo-inositol. Scores range from 0-7. Higher scores mean worse anxiety symptoms.
Measured: Weeks 2-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.
This assessment rates the clinician's view of the patient's anxiety severity before and after initiating myo-inositol. Scores range from 0-7. Higher scores mean more anxiety symptoms.
Measured: Weeks 2-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Brief Child Mania Rating Scale Parent Version (BCMRS-P) will be evaluated.
The BMRS-P is a 10-item inventory rated on a 4 point Likert type scale anchored by 0 (never/rare), 1 (sometimes), 2 (often), and 3 (very often). Its purpose is to measure changes in symptoms of pediatric bipolar disorder (PBD) as they change over time. Scores range from 0 to 30. Higher scores mean more symptom severity.
Measured: Week 1 & Weeks 10-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Improvement (PGIC-I) will be evaluated.
This scale evaluates participants' anxiety and assesses if there has been an improvement in clinical status. Answer options are "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", and "Much Worse".
Measured: Weeks 2-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Severity (PGIC-S) will be evaluated.
This scale is a child and parent self-report instrument used to evaluate participants' anxiety and assesses if there has been a decline in clinical status. Answer options are "0-None", "1-Mild", "2-Moderate", and "3-Severe" and describe symptoms of anxiety. Higher scores mean more anxiety symptoms and worse outcome.
Measured: Weeks 1-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Self-Report for Childhood Related Emotional Disorders (SCARED) will be evaluated.
The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia. The SCARED consists of 41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders. Scores range from 0-82. Scores greater than or equal to 25 indicate the presence of an anxiety disorder and scores in different items indicate the type of anxiety disorder.
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startAug 2023 (estimated)
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Why it stopped: Funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronald M. Glick, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Fine Foundation, Jarrow Formulas Inc
- Responsible party
- Sponsor-investigator, Ronald M. Glick, MD, University of Pittsburgh
- Investigators
- Ronald Glick, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811133
- Sponsor's protocol ID
- STUDY19100221
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2016
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request from other researchers, we will make available de-identified subject data, as appropriate.
Publications
Benjamin J, Agam G, Levine J, Bersudsky Y, Kofman O, Belmaker RH. Inositol treatment in psychiatry. Psychopharmacol Bull. 1995;31(1):167-75.
PubMed 7675981Benjamin J, Levine J, Fux M, Aviv A, Levy D, Belmaker RH. Double-blind, placebo-controlled, crossover trial of inositol treatment for panic disorder. Am J Psychiatry. 1995 Jul;152(7):1084-6. doi: 10.1176/ajp.152.7.1084.
PubMed 7793450Eden Evins A, Demopulos C, Yovel I, Culhane M, Ogutha J, Grandin LD, Nierenberg AA, Sachs GS. Inositol augmentation of lithium or valproate for bipolar depression. Bipolar Disord. 2006 Apr;8(2):168-74. doi: 10.1111/j.1399-5618.2006.00303.x.
PubMed 16542187Fux M, Levine J, Aviv A, Belmaker RH. Inositol treatment of obsessive-compulsive disorder. Am J Psychiatry. 1996 Sep;153(9):1219-21. doi: 10.1176/ajp.153.9.1219.
PubMed 8780431Levine J. Controlled trials of inositol in psychiatry. Eur Neuropsychopharmacol. 1997 May;7(2):147-55. doi: 10.1016/s0924-977x(97)00409-4.
PubMed 9169302Levine J, Barak Y, Gonzalves M, Szor H, Elizur A, Kofman O, Belmaker RH. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 1995 May;152(5):792-4. doi: 10.1176/ajp.152.5.792.
PubMed 7726322Palatnik A, Frolov K, Fux M, Benjamin J. Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder. J Clin Psychopharmacol. 2001 Jun;21(3):335-9. doi: 10.1097/00004714-200106000-00014.
PubMed 11386498Silverstone PH, McGrath BM, Kim H. Bipolar disorder and myo-inositol: a review of the magnetic resonance spectroscopy findings. Bipolar Disord. 2005 Feb;7(1):1-10. doi: 10.1111/j.1399-5618.2004.00174.x.
PubMed 15654927
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02811133
- Acronym / sponsor ID
- STUDY19100221
- Conditions
- Bipolar Disorder, Anxiety Disorders, Anxiety
- Keywords
- inositol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ronald M. Glick, MDUniversity, hospital or other
- Collaborators
- The Fine Foundation, Jarrow Formulas Inc
- Study start
- Aug 2023 (estimated)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 23 Jun 2016 (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.
This is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response.
Detailed description
Anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefits for bipolar depression in adults. This is an open multi-case control study. The investigators will enroll 20 children and adolescents ages 8-17 treated at the Child and Adolescent Bipolar Services (CABS) at Western Psychiatric Institute and Clinic. Participants' involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. Primary outcomes will include standard measures of mood and anxiety. Also, physiologic measures including body mass index and bedside glucose will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inositol | Experimental | Drug: InositolSubjects will receive inositol |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Evidence in the medical record confirming the DSM-V diagnosis of bipolar disorder. If this documentation is not in the record, then the appropriate sections of K-SADS will be administered to confirm the diagnosis.
- Evidence in the medical record confirming the DSM-V diagnosis of anxiety disorder including; separation anxiety disorder, generalized anxiety disorder, and/or social phobia. If this documentation is not present or is more than 2 years old, then the appropriate section of the K-SADS will be administered to confirm diagnosis.
- At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
- On a stable dose of psychotropic medications for at least one month, with no major changes projected.
Key exclusion criteria (5 listed)
- Presence of prominent diarrhea.
- Diagnosis of diabetes mellitus.
- Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
- Weight less than 20 kg.
- Known pregnancy.
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 |
|---|---|---|
| InositolAlso: MyoinositolSubjects will receive inositol | Drug | Inositol |
Primary outcome
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
Time frame: Weeks 1-12
This assessment rates the clinician's view of the patient's anxiety severity prior to and after initiating myo-inositol. Scores range from 0-7. Higher scores mean worse outcome.
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S).
Time frame: Weeks 1-12
This scale is a parent and child report tool that evaluates participants' anxiety and assesses if there has been a decline in clinical status. Answer options are "0-None", "1-Mild", "2-Moderate", and "3-Severe" and describe symptoms of anxiety. Higher scores mean worse outcome.
To measure the tolerability of myo-inositol, the number of participants who are able to remain on myo-inositol for the full treatment period (10-12 weeks) will be measured.
Time frame: Weeks 1-14
At study completion, the number of participants who remained on myo-inositol for the full 10-12 weeks will be counted.
To measure the tolerability of myo-inositol, the number of participants able to remain on the full dosage of myo-inositol for the full treatment period (10-12 weeks) will be measured.
Time frame: Weeks 3-8
Participants will be titrated up to the full dose of myo-inositol by Week 3 and will remain on the full dose for 6 weeks unless they cannot tolerate the dose. At study completion, the number of participants who remained on the full-dose of myo-inositol for the full 10-12 weeks will be counted.
To measure the safety and tolerability of myo-inositol, a change from baseline on the Physical Symptom Checklist (Side Effect Rating Scale) will be measured.
Time frame: Weeks 1-14
This assessment is a parent and child report measure. Its scores range from 0 to 60. Higher scores are indicative of more physical and psychological symptoms and worse outcome.
To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.
Time frame: Weeks 1-12
The B-SSRS probes for suicidal thoughts and behavior. The scores for both categories range from 0-5. If participants score greater than 1 on B-SSRS ideation or greater than 0 on B-SSRS behavior, then they cannot be enrolled or remain in the study. Higher scores mean worse outcome.
To measure the safety of myo-inositol, a fingerstick blood test will be done to measure glucose levels at the first and final study visits.
Time frame: Week 1 & Week 10-12
A glucometer will be used to test the blood glucose levels of participants.
To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.
Time frame: Weeks 1-12
Myo-inositol is dosed by the weight of the participant. To make sure the participant is taking the correct dose, weight will be measured at each study visit. Height will only be measured at Week 1 to calculate BMI. Also, change in weight or BMI will be followed.
7 secondary outcomes
To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.
Time frame: Weeks 1-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.
Time frame: Weeks 2-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.
Time frame: Weeks 2-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Brief Child Mania Rating Scale Parent Version (BCMRS-P) will be evaluated.
Time frame: Week 1 & Weeks 10-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Improvement (PGIC-I) will be evaluated.
Time frame: Weeks 2-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Severity (PGIC-S) will be evaluated.
Time frame: Weeks 1-12
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Self-Report for Childhood Related Emotional Disorders (SCARED) will be evaluated.
Time frame: Weeks 1-12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 7675981Benjamin J, Agam G, Levine J, Bersudsky Y, Kofman O, Belmaker RH. Inositol treatment in psychiatry. Psychopharmacol Bull. 1995;31(1):167-75.
- Background: PubMed 7793450Benjamin J, Levine J, Fux M, Aviv A, Levy D, Belmaker RH. Double-blind, placebo-controlled, crossover trial of inositol treatment for panic disorder. Am J Psychiatry. 1995 Jul;152(7):1084-6. doi: 10.1176/ajp.152.7.1084.
- Background: PubMed 16542187Eden Evins A, Demopulos C, Yovel I, Culhane M, Ogutha J, Grandin LD, Nierenberg AA, Sachs GS. Inositol augmentation of lithium or valproate for bipolar depression. Bipolar Disord. 2006 Apr;8(2):168-74. doi: 10.1111/j.1399-5618.2006.00303.x.
- Background: PubMed 8780431Fux M, Levine J, Aviv A, Belmaker RH. Inositol treatment of obsessive-compulsive disorder. Am J Psychiatry. 1996 Sep;153(9):1219-21. doi: 10.1176/ajp.153.9.1219.
- Background: PubMed 9169302Levine J. Controlled trials of inositol in psychiatry. Eur Neuropsychopharmacol. 1997 May;7(2):147-55. doi: 10.1016/s0924-977x(97)00409-4.
- Background: PubMed 7726322Levine J, Barak Y, Gonzalves M, Szor H, Elizur A, Kofman O, Belmaker RH. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 1995 May;152(5):792-4. doi: 10.1176/ajp.152.5.792.
- Background: PubMed 11386498Palatnik A, Frolov K, Fux M, Benjamin J. Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder. J Clin Psychopharmacol. 2001 Jun;21(3):335-9. doi: 10.1097/00004714-200106000-00014.
- Background: PubMed 15654927Silverstone PH, McGrath BM, Kim H. Bipolar disorder and myo-inositol: a review of the magnetic resonance spectroscopy findings. Bipolar Disord. 2005 Feb;7(1):1-10. doi: 10.1111/j.1399-5618.2004.00174.x.
- Individual participant dataSharing planned: Yes. Upon request from other researchers, we will make available de-identified subject data, as appropriate.
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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.
Ronald Glick, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inositol in people with Bipolar Disorder and Anxiety Disorders, run by Ronald M. Glick, MD 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 4 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: withdrawn, as of the sponsor's last update on 6 Oct 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S). (time frame: Weeks 1-12). 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?
On the ClinicalTrials.gov record for NCT02811133, which also lists 8 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 6 Oct 2023.