DepressionPhase 3OptimizeDNCT05944926
Improving Outcomes in Depression in Primary Care in a Low Resource Setting
A Phase 3 study testing Healthy Activity Program (HAP) and Antidepressant medication (fluoxetine) in people with Depression and Depressive Disorder, run by Harvard Medical School (HMS and HSDM) at 1 site in India.
Trial summary
The OptimizeD study aims to improve outcomes in depression in primary care in India. This study will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Healthy Activity Program (HAP) and Antidepressant medication (fluoxetine)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteIndia
- Study dates
- 18 Mar 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participants will be adults aged 18 or over of any gender attending one of the selected 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 permanently move out of the study area during the follow-up period.
- Patients with evidence of cognitive impairment.
- Patients who do not speak either English or Hindi.
- Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment
- Patients at imminent risk for suicide
- Patients from households in which another member has been recruited into the study
Trial locations and contacts
1 site in 1 country.
About this study
The OptimizeD study aims to improve outcomes in depression in primary care in India. This study will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine).
The study has two primary objectives:
- Use patient characteristics to generate a precision treatment rule based on baseline information for predicting in advance what works best for whom (and which patients are unlikely to respond to either treatment and should be referred to specialist care).
- Conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment based on the precision treatment rule.
Read the detailed description
Depression is the leading mental health contributor to the Global Burden of Disease. The World Health Organization's mhGAP initiative advocates the use of brief psychological therapies such as behavioral activation or antidepressant medications as first-line options for the treatment of moderate to severe depression in primary care settings, but not all patients will fully remit on either treatment. It is likely that different patients will respond to different treatments, but the optimal treatment for each individual remains unknown (and which patients are unlikely to respond to either treatment and should be referred to specialist care). Enhancing our ability to determine the optimal intervention for a particular patient has the potential to enhance the overall effectiveness of mental health care delivery in a more cost-efficient manner. This is a critical gap in knowledge in the treatment of depression across clinical settings globally.
The main objective of the OptimizeD study is to determine whether different patients respond differentially to brief psychological treatment or a widely used generic SSRI and, if so, whether one can optimize outcomes in a cost-effective fashion for primary care patients with moderate to severe depression.
The study has two specific aims and two exploratory aims:
- Specific Aim 1 (Clinical and Functional Outcomes): To evaluate the effectiveness of optimization via generating a precision treatment rule (PTR) on patients with moderate to severe depression randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The study will use machine learning to develop the PTR, using a wide range of clinical, socio-economic, and neuro-cognitive characteristics measured at baseline as predictors. The investigators hypothesize that patients randomized by chance to their optimal intervention will be more likely to remit and recover than patients who are not.
- Specific Aim 2 (Cost-effectiveness Outcomes): To assess the costs of optimal vs. non-optimal treatments and to conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment, based on the PTR developed in Aim 1. The investigators hypothesize that optimizing will be more cost-effective than not.
- Exploratory Aim 1 (Mediators): To explore whether one can use the PTR to make our tests of mediation more precise. Patients who respond differentially to different treatments adhere to different causal mechanisms, and inclusion of the PTR in interaction terms with the purported mediators should facilitate the detection of moderated mediation among patients who show specificity of response. The investigators will also consider whether treatment-related factors (e.g., adherence, quality) act as mediators of the effects of each treatment on remission and recovery. This exploratory aim will offer insights into mechanisms of action for each treatment.
- Exploratory Aim 2 (Genetic Predictors): To explore whether polygenic risk scores and other biomarkers can enhance the prediction of both general and differential response to either treatment.
As a secondary objective, the study will evaluate the effectiveness of optimization in the long-term. The investigators hypothesize that patients allocated to their optimized treatment will be more likely to recover than patients who are allocated to their non-optimal treatment.
All trial procedures used in the main trial were first evaluated in a pilot study (NCT06153004), which employed the same design and methods to assess feasibility across recruitment, randomization, retention, treatment adherence and fidelity, and data quality assurance.
- Conditions
- Depression, Depressive Disorder
- Being tested
- Healthy Activity Program (HAP), Antidepressant medication (fluoxetine)
- 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 (fluoxetine)Drug
Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day and 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. Participants who do not tolerate fluoxetine can be switched to escitalopram at week 6 (10mg which can be titrated up to 20 mg).
| 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 WHO. Receives: Behavioral: Healthy Activity Program (HAP) |
| Antidepressant medication (fluoxetine) | 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 (fluoxetine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression remission
Remission is defined as PHQ-9 total score < 5. The PHQ-9 is a self-report measure of depressive symptoms in the prior 2 weeks. 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. We will dichotomised the total score using the cut-off score of 5.
Measured: 3 months post recruitment
Secondary outcomes (6)
Cost-effectiveness of optimization
Cost-effectiveness analysis by comparing costs and effectiveness between those who were randomly allocated to their optimal treatment vs. those who were randomly allocated to a non-optimal treatment. Effectiveness will be measures by (1) likelihood of remission and (2) Quality Adjusted Life Years (QALYs). Costs of treatments include three components: system-level costs incurred at the health facility level, individual costs incurred by HAP counselors and Medical Officers in delivering each treatment, and costs incurred by patients for participating in the treatment. See section below for a description of these measures.
Measured: 3-, 6-, 9-, 12-months post recruitment
Depression severity, as measured by 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-, 6-, 9-, 12-months post recruitment
Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a 7-item self-report scale to screen for symptoms of generalized anxiety disorder. 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 21, where higher scores indicate more severe anxiety symptoms.
Measured: 3-, 6-, 9-, 12-months post recruitment
WHO Disability Assessment Schedule II (WHODAS-II)
The WHODAS-II consists of 12-items that capture level of functioning across six life domains including cognition, mobility, self-care, getting along, life activities, and participation in society. Each item ranges from 1 (none) to 5 (extreme), with total scores from 12-60. Raw scores are then converted to a summary score ranging from 0 (no disability) to 100 (full disability).
Measured: 3-, 6-, 9-, 12-months post recruitment
Minimal Clinically Important Difference (MCID)
We will use the anchor-based approach for estimating MCID that ties change in outcome on the PHQ-9 to the patient's subjective sense of improvement. We will follow Weobong (2017) methodology to compute this.
Measured: 3-, 6-, 9-, 12-months post recruitment
World Health Organization Well-Being Index (WHO-5)
The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: 3-, 6-, 9-, 12-months post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start18 Mar 2024
- Primary completion10 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- 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 treatment of depression
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Sangath, All India Institute of Medical Sciences, Bhopal, Vanderbilt University, Brigham and Women's Hospital, Centre for Addiction and Mental Health, Massachusetts General Hospital, Harvard School of Public Health (HSPH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Vikram Patel, Harvard Medical School (HMS and HSDM)
- Investigators
- Vikram Patel, MD, Principal investigator, Vikram_Patel@hms.harvard.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944926
- Sponsor's protocol ID
- IRB20-2144
- Other IDs
- CTRI/2024/01/061932, 1R01MH121632-01A1
- Acronym
- OptimizeD
- Status last verified
- May 2026
- First submitted
- 2 Jun 2023
- Last updated
- 22 May 2026
- 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 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.
Publications
Weobong B, Weiss HA, McDaid D, Singla DR, Hollon SD, Nadkarni A, Park AL, Bhat B, Katti B, Anand A, Dimidjian S, Araya R, King M, Vijayakumar L, Wilson GT, Velleman R, Kirkwood BR, Fairburn CG, Patel V. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial. PLoS Med. 2017 Sep 12;14(9):e1002385. doi: 10.1371/journal.pmed.1002385. eCollection 2017 Sep.
PubMed 28898283Pozuelo JR, Lahiri A, Singh RSP, Kushwah A, Khanduri M, Shukla A, Khan A, G S, Shende V, Parashar Y, Mehra YK, Bhan A, Kessler RC, Singla DR, Naslund JA, Choi KW, Cuijpers P, DeRubeis R, Herzallah MM, Lu C, Smoller JW, VanderWeele TJ, Rozatkar AR, Modak T, Joel MM, Biswas D, Atal S, Kulsum U, Hollon SD, Patel V. Optimizing treatment for depression in primary care using psychotherapy versus antidepressant medication in a low-resource setting: protocol for the OptimizeD randomized controlled trial. BMC Psychiatry. 2025 Jul 30;25(1):744. doi: 10.1186/s12888-025-07030-9.
PubMed 40739549Pozuelo JR, Lahiri A, Singh RSP, Kushwah A, Khanduri M, Shukla A, Khan A, G S, Shende V, Parashar Y, Mehra YK, Bhan A, Kessler RC, Singla DR, Naslund JA, Choi K, Cuijpers P, DeRubeis R, Herzallah M, Lu C, Smoller JW, VanderWeele TJ, Rozatkar A, Joel MM, Biswas D, Atal S, Kulsum U, Hollon SD, Patel V. Optimizing Treatment for Depression in Primary Care Using Psychotherapy Versus Antidepressant Medication in a Low-Resource Setting: Protocol for the OptimizeD Randomized Controlled Trial. Res Sq [Preprint]. 2025 May 23:rs.3.rs-6716211. doi: 10.21203/rs.3.rs-6716211/v1.
PubMed 40470239
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. 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
- ClinicalTrials.gov ID
- NCT05944926
- Acronym / sponsor ID
- OptimizeD / IRB20-2144
- Conditions
- Depression, Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Sangath, All India Institute of Medical Sciences, Bhopal, Vanderbilt University, Brigham and Women's Hospital, Centre for Addiction and Mental Health, Massachusetts General Hospital, Harvard School of Public Health (HSPH), National Institute of Mental Health (NIMH)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 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.
The OptimizeD study aims to improve outcomes in depression in primary care in India. This study will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine).
The study has two primary objectives:
- Use patient characteristics to generate a precision treatment rule based on baseline information for predicting in advance what works best for whom (and which patients are unlikely to respond to either treatment and should be referred to specialist care).
- Conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment based on the precision treatment rule.
Detailed description
Depression is the leading mental health contributor to the Global Burden of Disease. The World Health Organization's mhGAP initiative advocates the use of brief psychological therapies such as behavioral activation or antidepressant medications as first-line options for the treatment of moderate to severe depression in primary care settings, but not all patients will fully remit on either treatment. It is likely that different patients will respond to different treatments, but the optimal treatment for each individual remains unknown (and which patients are unlikely to respond to either treatment and should be referred to specialist care). Enhancing our ability to determine the optimal intervention for a particular patient has the potential to enhance the overall effectiveness of mental health care delivery in a more cost-efficient manner. This is a critical gap in knowledge in the treatment of depression across clinical settings globally.
The main objective of the OptimizeD study is to determine whether different patients respond differentially to brief psychological treatment or a widely used generic SSRI and, if so, whether one can optimize outcomes in a cost-effective fashion for primary care patients with moderate to severe depression.
The study has two specific aims and two exploratory aims:
- Specific Aim 1 (Clinical and Functional Outcomes): To evaluate the effectiveness of optimization via generating a precision treatment rule (PTR) on patients with moderate to severe depression randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The study will use machine learning to develop the PTR, using a wide range of clinical, socio-economic, and neuro-cognitive characteristics measured at baseline as predictors. The investigators hypothesize that patients randomized by chance to their optimal intervention will be more likely to remit and recover than patients who are not.
- Specific Aim 2 (Cost-effectiveness Outcomes): To assess the costs of optimal vs. non-optimal treatments and to conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment, based on the PTR developed in Aim 1. The investigators hypothesize that optimizing will be more cost-effective than not.
- Exploratory Aim 1 (Mediators): To explore whether one can use the PTR to make our tests of mediation more precise. Patients who respond differentially to different treatments adhere to different causal mechanisms, and inclusion of the PTR in interaction terms with the purported mediators should facilitate the detection of moderated mediation among patients who show specificity of response. The investigators will also consider whether treatment-related factors (e.g., adherence, quality) act as mediators of the effects of each treatment on remission and recovery. This exploratory aim will offer insights into mechanisms of action for each treatment.
- Exploratory Aim 2 (Genetic Predictors): To explore whether polygenic risk scores and other biomarkers can enhance the prediction of both general and differential response to either treatment.
As a secondary objective, the study will evaluate the effectiveness of optimization in the long-term. The investigators hypothesize that patients allocated to their optimized treatment will be more likely to recover than patients who are allocated to their non-optimal treatment.
All trial procedures used in the main trial were first evaluated in a pilot study (NCT06153004), which employed the same design and methods to assess feasibility across recruitment, randomization, retention, treatment adherence and fidelity, and data quality assurance.
Study design
- Primary purpose
- Health services research
- 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 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 WHO. |
| Antidepressant medication (fluoxetine) | Experimental | Drug: Antidepressant medication (fluoxetine)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 years and older
- 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 the selected 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 (8 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 permanently move out of the study area during the follow-up period.
- Patients with evidence of cognitive impairment.
- Patients who do not speak either English or Hindi.
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 (fluoxetine)Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day and 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. Participants who do not tolerate fluoxetine can be switched to escitalopram at week 6 (10mg which can be titrated up to 20 mg). | Drug | Antidepressant medication (fluoxetine) |
Primary outcome
Depression remission
Time frame: 3 months post recruitment
Remission is defined as PHQ-9 total score < 5. The PHQ-9 is a self-report measure of depressive symptoms in the prior 2 weeks. 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. We will dichotomised the total score using the cut-off score of 5.
6 secondary outcomes
Cost-effectiveness of optimization
Time frame: 3-, 6-, 9-, 12-months post recruitment
Depression severity, as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3-, 6-, 9-, 12-months post recruitment
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 3-, 6-, 9-, 12-months post recruitment
WHO Disability Assessment Schedule II (WHODAS-II)
Time frame: 3-, 6-, 9-, 12-months post recruitment
Minimal Clinically Important Difference (MCID)
Time frame: 3-, 6-, 9-, 12-months post recruitment
World Health Organization Well-Being Index (WHO-5)
Time frame: 3-, 6-, 9-, 12-months post recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 28898283Weobong B, Weiss HA, McDaid D, Singla DR, Hollon SD, Nadkarni A, Park AL, Bhat B, Katti B, Anand A, Dimidjian S, Araya R, King M, Vijayakumar L, Wilson GT, Velleman R, Kirkwood BR, Fairburn CG, Patel V. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial. PLoS Med. 2017 Sep 12;14(9):e1002385. doi: 10.1371/journal.pmed.1002385. eCollection 2017 Sep.
- Derived from this study: PubMed 40739549Pozuelo JR, Lahiri A, Singh RSP, Kushwah A, Khanduri M, Shukla A, Khan A, G S, Shende V, Parashar Y, Mehra YK, Bhan A, Kessler RC, Singla DR, Naslund JA, Choi KW, Cuijpers P, DeRubeis R, Herzallah MM, Lu C, Smoller JW, VanderWeele TJ, Rozatkar AR, Modak T, Joel MM, Biswas D, Atal S, Kulsum U, Hollon SD, Patel V. Optimizing treatment for depression in primary care using psychotherapy versus antidepressant medication in a low-resource setting: protocol for the OptimizeD randomized controlled trial. BMC Psychiatry. 2025 Jul 30;25(1):744. doi: 10.1186/s12888-025-07030-9.
- Derived from this study: PubMed 40470239Pozuelo JR, Lahiri A, Singh RSP, Kushwah A, Khanduri M, Shukla A, Khan A, G S, Shende V, Parashar Y, Mehra YK, Bhan A, Kessler RC, Singla DR, Naslund JA, Choi K, Cuijpers P, DeRubeis R, Herzallah M, Lu C, Smoller JW, VanderWeele TJ, Rozatkar A, Joel MM, Biswas D, Atal S, Kulsum U, Hollon SD, Patel V. Optimizing Treatment for Depression in Primary Care Using Psychotherapy Versus Antidepressant Medication in a Low-Resource Setting: Protocol for the OptimizeD Randomized Controlled Trial. Res Sq [Preprint]. 2025 May 23:rs.3.rs-6716211. doi: 10.21203/rs.3.rs-6716211/v1.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared through the 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.
Vikram Patel, MD principal investigator
Vikram_Patel@hms.harvard.edu
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 (fluoxetine) 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 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 remission (time frame: 3 months post recruitment). 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 NCT05944926, which also lists 3 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 22 May 2026.