DepressionNCT04744545
RCT of Adjunctive Curcumin and the Meru Health Program
A study testing Meru Health Program and Curcumin in people with Depression, run by Meru Health, Inc. at 1 site in United States.
Trial summary
This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Meru Health Program and Curcumin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Dec 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Patient presenting to the Meru Health online clinic
- Able to read and understand English
- Own a Smartphone
- Willing to commit to doing program practices for 10 minutes a day, 6 days a week for 12 weeks
- PHQ-9 of 10 or higher
Who cannot join
- Lifetime bipolar disorder or a psychotic disorder
- Possible cognitive impairment
- Substance use disorder in the past 3 months
- Active suicidal ideation with at least some intent to act
- Pregnant, breastfeeding, or desiring to become pregnant in the next 6 months
- Self-reported current suffering from a major medical illness including neurodegenerative/neuroinflammatory disorders, anemia, Alzheimer's disease, stroke, Parkinson's disease, or multiple sclerosis, autoimmune disorders, diabetes, inflammatory bowel disease, chronic obstructive pulmonary disease, asthma, coagulation disorder, cardiovascular disease, hypertension, chronic fatigue syndrome, fibromyalgia
- Self-reported current use of glucocorticoids, antibiotics, anticoagulant medications, antioxidant supplements (including curcumin), herbal supplements, or ω3 polyunsaturated fatty acids
- Self-reported past suffering from an infection or illness over the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Adjunctive Curcumin and the Meru Health Program for Adults With Depression
This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.
Read the detailed description
This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.
This feasibility study will use a randomized controlled trial of up to 60 adult patients with depression. Patients will be recruited through Facebook ads, complete online and telephone/Zoom screening and, if eligible, invited to participate in the 12-week Meru Health program. One group will be randomized to being in the MHP plus receiving curcumin supplementation (MHP-CUR) and the other will be randomized to being in the MHP only (MHP-only). The MHP overseen by a licensed therapist who is available to the participant as needed via text messaging and, when requested, telephone. The program is delivered via an app downloaded to the user's Smartphone made available via email. The lab orders will be sent to each patient's Ultalabs center of choice or, if preferred, done in the patient's home. All study participants (in both groups) will be asked to get their blood drawn before starting the program, 6 weeks into the program, and just after the 12-week program. Two vials of blood will be taken at each visit, one to test for high sensitivity-CRP (hs-CRP) levels and the other to test for interleukin (IL-6) levels. 2ml of serum is needed for each vial. Patients in both groups will receive a wearable HRVB device via US mail; patients in the MHP-CUR group will also receive curcumin supplements via US mail. All non-laboratory study assessments will be made via the app and online via email.
- Conditions
- Depression
- Being tested
- Meru Health Program, Curcumin
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meru Health ProgramBehavioural
12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app
CurcuminDietary supplement
1500mg/day curcumin plus black pepper to aid absorption
| Study group | Role | What they receive |
|---|---|---|
| Meru Health Program plus adjunctive curcumin (MHP-CUR) | Experimental | Meru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin. Receives: Behavioral: Meru Health Program; Dietary Supplement: Curcumin |
| Meru Health Program (MHP-ONLY) | Active comparator | Meru Health Program (12 week program) Receives: Behavioral: Meru Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Mean changes in the Patient Health Questionnaire, 9 item scale (PHQ-9) made during the program will be calculated. Scores range from 0 (no depression) to 27 (most severe depression)
Measured: 12 weeks
Patient-reported adverse events
The proportion of patients reporting at least one adverse event during the 12-week intervention will be reported.
Measured: during the 12 week program
Secondary outcomes (6)
Anxiety
Mean changes in the Generalized Anxiety Disorder-7 item scale (GAD-7) will be reported. GAD-7 scores range from 0 (no anxiety) to 21 (most severe anxiety)
Measured: 12 weeks
Burnout
The proportion of patients with changes in burnout will be reported. A validated, single-item burnout question will be used to assess burnout that has 5 response categoreis ranging from 1 (no burnout) to 5 (completed burned out) and dichotomized as <3 (no to low burnout) versus >=3 (at least moderate levels of burnout)
Measured: 12 weeks
Worker productivity and activity impairment
The mean percent difference in each of the 4 subscales of the Worker Productivity and Activity Impairment (WPAI) scale will be reported. Subscales include absenteeism, presenteeism, overall worker productivity impairment, and impairment with daily activities and range from 0 (no impairment) to 100% (complete impairment).
Measured: 12 weeks
Therapist rating
The proportion of patients who reported being satisfied with their program therapist will be reported as dichotmized by a 5-category scale that ranges from 1 (not at all satisfied) to 5 (extremely satisfied). Responses "1" and "2" (not at all satisfied and not satisfied) will be combined into a "not satisfied" dichotomous category and responses 2 (satisfied), 3 (very satisfied) and 4 (extremely satisfied) will be combined into a "satisfied" dichotomous category, with the proportion of patients falling into each category being reported.
Measured: 12 weeks
Interleukin-6
Mean changes in Interleukin-6 (IL-6) will be calculated for each participant to measure changes in inflammation made during the program.
Measured: 12 weeks
High Sensitivity C Reactive Protein
Mean changes in high-sensitivity c reactive protein (hs-crp) will be calculated for each participant to measure changes in inflammation made during the program.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two study groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meru Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744545
- Sponsor's protocol ID
- #20-MERU-106
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Adjunctive Curcumin and the Meru Health Program for Adults With Depression
- ClinicalTrials.gov ID
- NCT04744545
- Acronym / sponsor ID
- #20-MERU-106
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Meru Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Feb 2021 (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 randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.
Detailed description
This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.
This feasibility study will use a randomized controlled trial of up to 60 adult patients with depression. Patients will be recruited through Facebook ads, complete online and telephone/Zoom screening and, if eligible, invited to participate in the 12-week Meru Health program. One group will be randomized to being in the MHP plus receiving curcumin supplementation (MHP-CUR) and the other will be randomized to being in the MHP only (MHP-only). The MHP overseen by a licensed therapist who is available to the participant as needed via text messaging and, when requested, telephone. The program is delivered via an app downloaded to the user's Smartphone made available via email. The lab orders will be sent to each patient's Ultalabs center of choice or, if preferred, done in the patient's home. All study participants (in both groups) will be asked to get their blood drawn before starting the program, 6 weeks into the program, and just after the 12-week program. Two vials of blood will be taken at each visit, one to test for high sensitivity-CRP (hs-CRP) levels and the other to test for interleukin (IL-6) levels. 2ml of serum is needed for each vial. Patients in both groups will receive a wearable HRVB device via US mail; patients in the MHP-CUR group will also receive curcumin supplements via US mail. All non-laboratory study assessments will be made via the app and online via email.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two study groups.
| Arm | Type | Receives |
|---|---|---|
| Meru Health Program plus adjunctive curcumin (MHP-CUR) | Experimental | Behavioral: Meru Health Program, Dietary Supplement: CurcuminMeru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin. |
| Meru Health Program (MHP-ONLY) | Active comparator | Behavioral: Meru Health ProgramMeru Health Program (12 week program) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Patient presenting to the Meru Health online clinic
- Able to read and understand English
- Own a Smartphone
- Willing to commit to doing program practices for 10 minutes a day, 6 days a week for 12 weeks
Key exclusion criteria (8 listed)
- Lifetime bipolar disorder or a psychotic disorder
- Possible cognitive impairment
- Substance use disorder in the past 3 months
- Active suicidal ideation with at least some intent to act
- Pregnant, breastfeeding, or desiring to become pregnant in the next 6 months
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 |
|---|---|---|
| Meru Health Program12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app | Behavioural | Meru Health Program (MHP-ONLY), Meru Health Program plus adjunctive curcumin (MHP-CUR) |
| Curcumin1500mg/day curcumin plus black pepper to aid absorption | Dietary supplement | Meru Health Program plus adjunctive curcumin (MHP-CUR) |
Primary outcome
Depression
Time frame: 12 weeks
Mean changes in the Patient Health Questionnaire, 9 item scale (PHQ-9) made during the program will be calculated. Scores range from 0 (no depression) to 27 (most severe depression)
Patient-reported adverse events
Time frame: during the 12 week program
The proportion of patients reporting at least one adverse event during the 12-week intervention will be reported.
6 secondary outcomes
Anxiety
Time frame: 12 weeks
Burnout
Time frame: 12 weeks
Worker productivity and activity impairment
Time frame: 12 weeks
Therapist rating
Time frame: 12 weeks
Interleukin-6
Time frame: 12 weeks
High Sensitivity C Reactive Protein
Time frame: 12 weeks
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 13 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meru Health Program and Curcumin in people with Depression, run by Meru Health, Inc. 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 6 inclusion and 8 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 13 Jul 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.
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?
Depression (time frame: 12 weeks). 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 13 Jul 2023.