DepressionPhase 3NCT06153004
OptimizeD Pilot Study
A Phase 3 study testing Healthy Activity Program (HAP) and Antidepressant medication (ADM) in people with Depression and Depressive Disorder, run by Harvard Medical School (HMS and HSDM) at 1 site in India.
Trial summary
This pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Healthy Activity Program (HAP) and Antidepressant medication (ADM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 31 Mar 2024
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be adults aged 18 or over of any gender attending one of eight Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).
Who cannot join
- Women who are pregnant or are breastfeeding or lactating
- Patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder.
- Participants planning to move out of the study area during the follow-up period.
- Patients over 65 years of age with evidence of cognitive impairment - Patients who do not speak the study or local language (English or Hindi)
- Patients who are undergoing treatment for depression at the time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Outcomes in Depression in Primary Care in a Low Resource Setting: Evidence From a Pilot Study
This pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication.
The pilot study has two primary objectives:
- Evaluate the feasibility and acceptability of the study
- Collect essential outcome data in preparation for the larger trial
Read the detailed description
This pilot study will play a pivotal role in preparation for the forthcoming larger clinical trial, named the OptimizeD study, scheduled for launch in March 2024 (NCT05944926).
The primary objective of the OptimizeD study is to explore whether different patients respond differentially to a brief psychological treatment, known as the Healthy Activity Program, or a widely used generic Selective Serotonin Reuptake Inhibitor (fluoxetine). If such differences exist, this study aims to explore whether one can develop a machine learning-generated precision treatment rule to predict the most effective treatment based on individual baseline characteristics.
The pilot study has two primary objectives:
- Evaluate the feasibility and acceptability of the study: This pilot study will focus on assessing the feasibility and acceptability of the research protocol, including recruitment strategies, data collection methods, interventions, and risk management procedures. This evaluation will help refine and tailor the study procedures and play a critical role in setting the stage for the subsequent OptimizeD study.
- Collect essential outcome data in preparation for the larger trial:
This study will test and refine the data instruments, gather initial data on efficacy, and refine the baseline assessment (which will serve as the cornerstone for the development of the precision treatment rule).
- Conditions
- Depression, Depressive Disorder
- Being tested
- Healthy Activity Program (HAP), Antidepressant medication (ADM)
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Activity Program (HAP)Behavioural
HAP, delivered over 6-8 sessions by non-specialist healthcare workers, has behavioural activation as the core psychological strategy along with other strategies such as problem-solving and activation of social networks.
Antidepressant medication (ADM)Drug
Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day which can be raised to 40 mg/day (the maximum mandated by treatment guidelines for primary care in India) at week 3 or 6 for patients who have yet to remit. Patients who cannot tolerate fluoxetine will be switched to escitalopram.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Activity Program (HAP) | Experimental | HAP is a brief psychological treatment adapted from behavioral activation therapy, an empirically supported psychological treatment recommended by the World Health Organization. Receives: Behavioral: Healthy Activity Program (HAP) |
| Antidepressant medication (ADM) | Experimental | Fluoxetine is a selective serotonin reuptake inhibitors (SSRIs) and one of the safest medications used to treat depression. It is a routinely used medication and part of the Essential Drug List (EDL) in India. Receives: Drug: Antidepressant medication (ADM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by recruitment rate
The investigators will assess enrolment rate for eligible participants
Measured: 3-months
Feasibility as measured by retention rate
The investigators will evaluate retention rates, which are calculated as the ratio of patients who complete the study to the total number of patients enrolled
Measured: 3-months
Feasibility of study assessments
The investigators will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.
Measured: 3-months
Acceptability of interventions by participants
The investigators will assess treatment compliance. For the HAP arm, this will be defined as having completed at least six sessions. For the ADM arm, this will be defined as having completed more than 80% of the recommended 12-week course of antidepressant medication.
Measured: 3-months
Secondary outcomes (1)
Change from Baseline in Depressive Symptoms
The investigators will measure depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale to screen for symptoms of depression. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Aug 2023
- Primary completion10 Mar 2024
- Study completion31 Mar 2024
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fluoxetine versus a contextually adapted version of behavioral activation called the Healthy Activity Program (HAP) delivered by non-specialists for the treatment of depression
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard School of Public Health (HSPH), Massachusetts General Hospital, Centre for Addiction and Mental Health, Brigham and Women's Hospital, Vanderbilt University, All India Institute of Medical Sciences, Bhopal, Sangath
- Responsible party
- Principal investigator, Vikram Patel, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153004
- Sponsor's protocol ID
- IRB20-2144-pilot
- Other IDs
- 1R01MH121632-01A1
- Status last verified
- Apr 2024
- First submitted
- 22 Nov 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared through the National Institute of Mental Health (NIMH) Data Archive. To ensure participant privacy and data security, all shared data will be de-identified according to established protocols and guidelines. The data sharing plan will be periodically reviewed and updated, as necessary, to align with evolving best practices, policies, and guidelines for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Depression in Primary Care in a Low Resource Setting: Evidence From a Pilot Study
- ClinicalTrials.gov ID
- NCT06153004
- Acronym / sponsor ID
- IRB20-2144-pilot
- Conditions
- Depression, Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard School of Public Health (HSPH), Massachusetts General Hospital, Centre for Addiction and Mental Health, Brigham and Women's Hospital, Vanderbilt University, All India Institute of Medical Sciences, Bhopal, Sangath
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Dec 2023 (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 pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication.
The pilot study has two primary objectives:
- Evaluate the feasibility and acceptability of the study
- Collect essential outcome data in preparation for the larger trial
Detailed description
This pilot study will play a pivotal role in preparation for the forthcoming larger clinical trial, named the OptimizeD study, scheduled for launch in March 2024 (NCT05944926).
The primary objective of the OptimizeD study is to explore whether different patients respond differentially to a brief psychological treatment, known as the Healthy Activity Program, or a widely used generic Selective Serotonin Reuptake Inhibitor (fluoxetine). If such differences exist, this study aims to explore whether one can develop a machine learning-generated precision treatment rule to predict the most effective treatment based on individual baseline characteristics.
The pilot study has two primary objectives:
- Evaluate the feasibility and acceptability of the study: This pilot study will focus on assessing the feasibility and acceptability of the research protocol, including recruitment strategies, data collection methods, interventions, and risk management procedures. This evaluation will help refine and tailor the study procedures and play a critical role in setting the stage for the subsequent OptimizeD study.
- Collect essential outcome data in preparation for the larger trial:
This study will test and refine the data instruments, gather initial data on efficacy, and refine the baseline assessment (which will serve as the cornerstone for the development of the precision treatment rule).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Fluoxetine versus a contextually adapted version of behavioral activation called the Healthy Activity Program (HAP) delivered by non-specialists for the treatment of depression
| Arm | Type | Receives |
|---|---|---|
| Healthy Activity Program (HAP) | Experimental | Behavioral: Healthy Activity Program (HAP)HAP is a brief psychological treatment adapted from behavioral activation therapy, an empirically supported psychological treatment recommended by the World Health Organization. |
| Antidepressant medication (ADM) | Experimental | Drug: Antidepressant medication (ADM)Fluoxetine is a selective serotonin reuptake inhibitors (SSRIs) and one of the safest medications used to treat depression. It is a routinely used medication and part of the Essential Drug List (EDL) in India. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be adults aged 18 or over of any gender attending one of eight Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).
Key exclusion criteria (5 listed)
- Women who are pregnant or are breastfeeding or lactating
- Patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder.
- Participants planning to move out of the study area during the follow-up period.
- Patients over 65 years of age with evidence of cognitive impairment - Patients who do not speak the study or local language (English or Hindi)
- Patients who are undergoing treatment for depression at the time of recruitment
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 |
|---|---|---|
| Healthy Activity Program (HAP)HAP, delivered over 6-8 sessions by non-specialist healthcare workers, has behavioural activation as the core psychological strategy along with other strategies such as problem-solving and activation of social networks. | Behavioural | Healthy Activity Program (HAP) |
| Antidepressant medication (ADM)Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day which can be raised to 40 mg/day (the maximum mandated by treatment guidelines for primary care in India) at week 3 or 6 for patients who have yet to remit. Patients who cannot tolerate fluoxetine will be switched to escitalopram. | Drug | Antidepressant medication (ADM) |
Primary outcome
Feasibility as measured by recruitment rate
Time frame: 3-months
The investigators will assess enrolment rate for eligible participants
Feasibility as measured by retention rate
Time frame: 3-months
The investigators will evaluate retention rates, which are calculated as the ratio of patients who complete the study to the total number of patients enrolled
Feasibility of study assessments
Time frame: 3-months
The investigators will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.
Acceptability of interventions by participants
Time frame: 3-months
The investigators will assess treatment compliance. For the HAP arm, this will be defined as having completed at least six sessions. For the ADM arm, this will be defined as having completed more than 80% of the recommended 12-week course of antidepressant medication.
1 secondary outcome
Change from Baseline in Depressive Symptoms
Time frame: 3-months
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 9 Apr 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared through the National Institute of Mental Health (NIMH) Data Archive. To ensure participant privacy and data security, all shared data will be de-identified according to established protocols and guidelines. The data sharing plan will be periodically reviewed and updated, as necessary, to align with evolving best practices, policies, and guidelines for data sharing.
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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 Phase 3 study testing Healthy Activity Program (HAP) and Antidepressant medication (ADM) in people with Depression and Depressive Disorder, run by Harvard Medical School (HMS and HSDM) at 1 site in India.
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 1 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: finished, as of the sponsor's last update on 9 Apr 2024. 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 India. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Feasibility as measured by recruitment rate (time frame: 3-months). The study lists 4 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 9 Apr 2024.