Improving Outcomes in Depression in Primary Care in a Low Resource Setting

Plain English Summary

Improving Outcomes in Depression in Primary Care in a Low Resource Setting is a Phase 3 clinical trial sponsored by Harvard Medical School (HMS and HSDM) studying Depression, Depressive Disorder. This study tests if a personalized approach to treating moderate to severe depression in primary care is better than standard treatment. It is for adults in India diagnosed with moderate to severe depression who are seeking care at specific primary health centers. Participants will be randomly assigned to receive either a talk therapy called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). Alternatives include standard medical care for depression, which may involve medication or therapy, or seeking specialized mental health services. The trial aims to enroll 1500 participants.

Official 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). The study has two primary objectives: 1. 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). 2. 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and over with moderate to severe depression (scoring 10 or above on the PHQ-9 questionnaire). Cannot join if you are pregnant, breastfeeding, have a history of psychosis or bipolar disorder, have cognitive impairment, or are at immediate risk of suicide. Must be able to speak English or Hindi and plan to stay in the study area for the duration of the follow-up. Cannot be currently undergoing depression treatment or have recently completed it. This trial is studying Depression, Depressive Disorder, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures whether patients achieve remission from depression symptoms within 3 months, meaning their symptoms significantly improve or disappear. The specific primary outcome measures are: Depression remission (3 months post recruitment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for effective and personalized depression treatment in low-resource settings, aiming to improve outcomes and reduce the burden of the illness. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Depression, Depressive Disorder, where improved treatment options are needed.

Investor Insight

This trial targets a large unmet need for mental health services in India, with potential for a scalable and cost-effective treatment model that could be adopted globally. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1500 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what the potential benefits and risks are. Participation involves being randomly assigned to either a talk therapy program or antidepressant medication and attending regular follow-up appointments. The Healthy Activity Program (HAP) involves 6-8 sessions with a healthcare worker focused on behavioral activation and problem-solving. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 1,500 participants

Interventions

• BEHAVIORAL: 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.
• DRUG: 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).

Primary Outcomes

• Depression remission (3 months post recruitment)

Secondary Outcomes

• Cost-effectiveness of optimization (3-, 6-, 9-, 12-months post recruitment)
• Depression severity, as measured by the Patient Health Questionnaire-9 (PHQ-9) (3-, 6-, 9-, 12-months post recruitment)
• Generalized Anxiety Disorder Assessment (GAD-7) (3-, 6-, 9-, 12-months post recruitment)
• WHO Disability Assessment Schedule II (WHODAS-II) (3-, 6-, 9-, 12-months post recruitment)
• Minimal Clinically Important Difference (MCID) (3-, 6-, 9-, 12-months post recruitment)

Full Eligibility Criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

1. Women who are pregnant or are breastfeeding or lactating
2. Patients with a history of psychosis, including schizophrenia spectrum disorders or bipolar disorder.
3. Participants planning to permanently move out of the study area during the follow-up period.
4. Patients with evidence of cognitive impairment.
5. Patients who do not speak either English or Hindi.
6. Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment
7. Patients at imminent risk for suicide
8. Patients from households in which another member has been recruited into the study

Trial Locations

• Sangath, Bhopal, Madhya Pradesh, India

Frequently Asked Questions

Related Conditions

• Depression
• Major Depressive Disorder
• Anxiety Disorders
• Mental Health
• Primary Care
• Low-Resource Settings
• Behavioral Activation
• Psychotherapy
• Antidepressant Medication
• Public Health

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