The Long-Term Impact of Pharmacotherapy in India

Last registered on January 27, 2024


Trial Information

General Information

The Long-Term Impact of Pharmacotherapy in India
Initial registration date
December 20, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
December 21, 2023, 8:07 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
January 27, 2024, 6:40 PM EST

Last updated is the most recent time when changes to the trial's registration were published.


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Primary Investigator


Other Primary Investigator(s)

PI Affiliation

Additional Trial Information

In development
Start date
End date
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
This study evaluates the long-run impact of a single course of pharmacotherapy in Karnataka, India. Angelucci and Bennett (2024) showed that offering pharmacotherapy to depressed adults improved mental health and increased human capital investment in older children. However, the long-term effects of a single course of antidepressants are unknown. We will resurvey the original study participants to evaluate the 7-year impact of this intervention on depression severity, depression awareness and stigma, children's human capital investment, impacts in the household, and possible pathways.
External Link(s)

Registration Citation

Angelucci, Manuela and Daniel Bennett. 2024. "The Long-Term Impact of Pharmacotherapy in India." AEA RCT Registry. January 27.
Sponsors & Partners

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Experimental Details


This study resurveys the participants in a depression treatment study described in Angelucci and Bennett (2024). The trial was conducted from 2016-2018. The PC intervention provided eight months of free psychiatric care through the Shridevi Institute of Medical Sciences and Research Hospital. Shridevi is an accredited private hospital in Tumkur, Karnataka, near the study area. The facility has 750 beds, 80 percent of which are allocated for pro bono care of disadvantaged patients. The hospital sometimes receives patients from GASS. The initial visit included a diagnosis, an explanation of the significance of mental illness, and an individualized course of medical treatment. Patients returned for monthly follow-up visits. The most commonly prescribed anti-depressants were Selective Serotonin Reuptake Inhibitors (SSRIs). These drugs are generally not under patent and are available inexpensively in India. They are widely used and have relatively few well-tolerated side effects. In addition to treating depression, the PC intervention may raise awareness and increase the salience of depression in the household, which could lead to additional effects.

The livelihoods assistance (LA) intervention provided two group meetings and personalized livelihoods assistance during the first two months of the study. Overall, this intervention had no short- or medium-term independent effects. Thus, it is not the focus of our study of long-run impacts.
Intervention Start Date
Intervention End Date

Primary Outcomes

Primary Outcomes (end points)
There 2 primary outcomes: (1) contemporaneous depression severity, which we will measure by standardizing the PHQ-9 score; (2) retrospective history of depression, which we will measure as the total number of months in which the respondent has been depressed since 2018 (summing up multiple spells of depression).

Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Depression awareness
Depression stigma
Educational attainment for children aged 13-18 at baseline
Human capital investment among current children
Exposure to negative economic shocks
Work time and earnings (from 7-day recall)
Household consumption
Durable good ownership
Hygiene and sanitation
Risk intolerance
Cognitive performance
Subjective wellbeing
Participation in household decisions
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
In this study, we will resurvey the participants in our previous project (Angelucci and Bennett, 2024) to study the 7-year impacts of depression treatment.

In the first study, we conducted field work in a peri-urban region northwest of Bangalore, Karnataka. Our study area comprises 506 localities with at least 40 households within the catchment area of our partner NGO in the Doddaballapur, Korategere, and Gauribidanur districts.

We collaborated with Grameena Abudaya Seva Samsthe (GASS), a local social service organization that has worked with people with physical and mental disabilities since 2001. GASS aims to improve mental health and patient wellbeing by facilitating psychiatric care and providing livelihoods assistance. To support psychiatric care, GASS organizes walk-in clinics, sets up appointments, and helps transport people to health centers. It provides livelihoods assistance by counseling patients about employment and other earnings opportunities and by helping patients obtain training and small loans as appropriate.

We used a cluster-randomized design to cross-randomize psychiatric care (PC) and livelihoods assistance (LA) by locality. Before starting recruitment, we stratified the randomization by district and terciles of a locality socioeconomic index based on the 2011 Census of India. We screened about forty households per locality, with the target of selecting 1-2 participants per locality.

We sampled participants through a door-skip pattern in which the skips were proportional to locality size. Once at the household, surveyors randomly chose an available adult to screen for eligibility. We screened people for depression symptoms with the PHQ-9 depression severity scale. To obtain a sample of mildly or moderately depressed people, we recruited subjects with PHQ-9 scores of 9-20. In total, surveyors screened 6446 people in order to enroll a study sample of 1000 participants across 506 localities. We ultimately enrolled 395 participants (from 204 localities) in the control arm, 207 participants (from 99 localities) in the PC arm, 205 participants (from 102 localities) in the LA arm, and 195 participants (from 101 localities) in the PC/LA arm.

Experimental Design Details
Not available
Randomization Method
We randomly assigned localities to treatment arms using a computer.
Randomization Unit
Was the treatment clustered?

Experiment Characteristics

Sample size: planned number of clusters
Sample size: planned number of observations
About 700 (assuming a 30% attrition).
Sample size (or number of clusters) by treatment arms
We ultimately enrolled 395 participants (from 204 localities) in the control arm, 207 participants (from 99 localities) in the PC arm, 205 participants (from 102 localities) in the LA arm, and 195 participants (from 101 localities) in the PC/LA arm. We expect 30% attrition from these figures.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)

Institutional Review Boards (IRBs)

IRB Name
DAI Research & Advisory Services PVT LTD -IRB
IRB Approval Date
IRB Approval Number