Depression, UnipolarSMART-DAPPERNCT03466346
SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project
A study testing Fluoxetine and Interpersonal Psychotherapy in people with Depression, Unipolar and Posttraumatic Stress Disorder, run by University of California, San Francisco at 3 sites in Kenya.
Trial summary
Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Unipolar, Posttraumatic Stress Disorder, Trauma
- What is being tested?
- Fluoxetine and Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,162 participants
- Where
- 3 sitesKenya
- Study dates
- 31 Aug 2020to 6 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for depression and/or PTSD
- Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) 18 years or older
Who cannot join
- Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation)
- acute suicidality requiring higher level of care
- drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher)
- history of mania or requiring treatment for hypomania
- Outside mental health treatment during the study treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team).
Trial locations and contacts
3 sites in 1 country.
Kenya3 sites
Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
Kisumu
Kisumu County Hospital
Kisumu
Lumumba Health Center
Kisumu
About this study
Official title: A Sequential, Multiple Assignment Randomized Trial (SMART) for Non-specialist Treatment of Common Mental Disorders in Kenya: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research (DAPPER) Project
Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.
Read the detailed description
Mental disorders are a leading cause of global disability, driven by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Despite nearly 15 years of efficacy research showing that local non-specialists can provide evidence-based care for depression and anxiety in LMICs, few studies have advanced to the critical next step: identifying strategies for sustainable "real world" non-specialist treatment including integration with existing healthcare platforms and response to common clinical dilemmas, such as what treatment to start with and how to modify it.
Given the need to personalize treatment to achieve remission (absence of disease) and the scarcity of mental health specialists in LMICs, successful reduction of population-level disability caused by depression and anxiety requires (1) evidence-based strategies for first-line and second-line (non-remitter) treatment delivered by non-specialists, with (2) confirmation of presumed mechanism of action and (3) patient-level moderators of treatment outcome to inform personalized, non-specialist treatment algorithms.
The research team has worked in western Kenya for 6 years with a UCSF-Kenya collaboration that supports integrated HIV services at over 70 primary healthcare facilities in Kisumu County (Family AIDS Care and Education Services [FACES]). Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) (26%) and Posttraumatic Stress Disorder (PTSD) (35%). Kenyan leaders lack an evidence base for two essential treatments - psychotherapy and second generation antidepressants- without which scale-up will fall short of its potential. We conducted a randomized, controlled trial in Kisumu County of Interpersonal Psychotherapy (IPT) delivered by non-specialists for HIV-positive patients with MDD and PTSD. In our study, IPT achieved full remission of MDD and PTSD in the majority of participants.
Given the high prevalence of MDD-PTSD co-morbidity, we will collaborate with the FACES team providing services to Kisumu County Hospital (KCH) primary care outpatient clinic (~10,000 patients/month) to conduct a randomized trial of IPT versus fluoxetine for MDD and/or PTSD. Local non-specialists will be trained in mental health care for the SMART and hired through the Kenyan Ministry of Health to work at KCH. SMART participants will be randomized to: (1) first line treatment with IPT or fluoxetine; (2) second line treatment for non-remitters- treatment "switch" (e.g., IPT to fluoxetine) or treatment "combination" (e.g., addition of IPT to fluoxetine). Research with mental health specialists in high income countries suggests that antidepressants and psychotherapy have equivalent short-term efficacy and that psychotherapy yields superior long-term relapse prevention. We will test the role of previously identified mechanisms in mediating remission and key moderators of treatment effect. Results of moderator and Q learning analyses will produce first and second-line non-specialist treatment algorithms.
- Conditions
- Depression, Unipolar, Posttraumatic Stress Disorder, Trauma
- Being tested
- Fluoxetine, Interpersonal Psychotherapy
- Medical subject headings
- Depressive Disorder, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.
Interpersonal PsychotherapyBehavioural
Also called IPT
IPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal psychotherapy | Active comparator | IPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area. Receives: Behavioral: Interpersonal Psychotherapy |
| fluoxetine | Active comparator | Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression. Receives: Drug: Fluoxetine |
| Fluoxetine after IPT | Active comparator | participants who do not remit from MDD and PTSD after treatment with IPT may be randomized to fluoxetine. Receives: Drug: Fluoxetine |
| IPT after fluoxetine | Active comparator | participants who do not remit from MDD and PTSD after treatment with fluoxetine may be randomized to IPT. Receives: Behavioral: Interpersonal Psychotherapy |
| IPT + fluoxetine | Active comparator | participants who do not remit from MDD and PTSD after treatment with fluoxetine may be randomized to IPT + fluoxetine. Receives: Drug: Fluoxetine; Behavioral: Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Depression at End of Treatment
Number of Participants with Major Depression. The Beck Depression Inventory-Second Edition (BDI-II) was used and a score of 19 or greater was defined as positive for major depression. BDI-II score below 19 is defined as negative for major depression. Scores range from 0 to 63 with higher total scores indicating more severe depressive symptoms.
Measured: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)
Number of Participants With PTSD
Number of Participants with PTSD. The PTSD Checklist for DSM-5 (PCL-5) was used and score of 23 or greater is defined as positive for PTSD. PCL-5 score below 23 is defined as negative for PTSD. Score range from 0 to 80 with higher total scores indicating more severe PTSD symptoms.
Measured: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start31 Aug 2020
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- fluoxetine versus interpersonal psychotherapy (IPT) for treatment of Major Depressive Disorder (MDD) and/or Posttraumatic Stress Disorder (PTSD)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi, National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of California, San Diego, Makerere University
- Responsible party
- Sponsor
- Investigators
- Muthoni J Mathai, MDChB, MMed, Principal investigator, University of NairobiSusan M Meffert, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466346
- Sponsor's protocol ID
- 1R01MH115512 1R01MH113722-01A1
- Other IDs
- 1R01MH115512, 1R01MH113722-01A1
- Acronym
- SMART-DAPPER
- Status last verified
- Nov 2025
- First submitted
- 2 Mar 2018
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIMH Data Archive The National Institutes of Health (NIH) and NIMH have developed a federation of data repositories called the NIMH Data Archive (NDA) to store the collection of data from participants in research studies related to mental health, regardless of the source of funding. The extensive information collected by these studies, and subsequently stored in the National Database for Autism Research (NDAR), the NIH Pediatric MRI Repository (PedsMRI), the National Database for Clinical Trials Related to Mental Illness (NDCT), and the Research Domain Criteria Database (RDoCdb) provides a rare and valuable scientific resource. The NIH and the NIMH seek to encourage the use of these resources to achieve rapid scientific progress. In order to take full advantage of such resources and maximize their research value, it is important that data be made available, on appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner.
Publications
Mwai D, Meffert SM, Olwanda EE, Mathai MA, Ongeri L, Burger RL, Mbwayo A, Rota G, Otieno A, Cohen CR, Bukusi D, Aarons GA, Neylan TC, McCulloch CE, Jin C, Akena D, Kahonge S, Kahn JG. Productivity benefits of treatment of depression and post-traumatic stress disorder in Kenya. BMJ Glob Health. 2025 Nov 3;10(11):e018204. doi: 10.1136/bmjgh-2024-018204.
PubMed 41184028Burger RL, Meffert SM meffert, Ongeri L, Wangia J, Wambura R, Ajore P, Rota G, Otieno A, Obura RR, Muchembre P, Bukusi D, Mbwayo A, Neylan TC, Akena D, Jin C, McCulloch C, Mathai MA. Factors associated with fluoxetine adherence among outpatients with common mental disorders in Western Kenya. BMJ Glob Health. 2025 Aug 25;10(8):e017929. doi: 10.1136/bmjgh-2024-017929.
PubMed 40854809Olwanda E, Mwai D, Mathai M, Burger R, Ongeri L, Bukusi D, Mbwayo A, Rota G, Otieno A, Rota R, Meffert S, Kahn JG. Cost-Benefit Analysis of Interpersonal Therapy and Fluoxetine for Treating Depression and PTSD in Primary Care Settings in Kenya. Res Sq [Preprint]. 2025 Jul 28:rs.3.rs-6977800. doi: 10.21203/rs.3.rs-6977800/v1.
PubMed 40766223Meffert S, Mathai M, Neylan T, Mwai D, Onyango DO, Rota G, Otieno A, Obura RR, Wangia J, Opiyo E, Muchembre P, Oluoch D, Wambura R, Mbwayo A, Kahn JG, Cohen CR, Bukusi D, Aarons GA, Burger RL, Jin C, McCulloch C, Kahonge S, Ongeri L. Preference of mHealth versus in-person treatment for depression and post-traumatic stress disorder in Kenya: demographic and clinical characteristics. BMJ Open. 2024 Nov 18;14(11):e083094. doi: 10.1136/bmjopen-2023-083094.
PubMed 39557549Getahun M, Mathai MA, Rota G, Allen A, Burger RL, Opiyo E, Oluoch D, Wangia J, Wambura R, Mbwayo A, Muchembre P, Obura RR, Neylan TC, Aarons GA, Ongeri L, Meffert SM. "The peace that I wanted, I got": Qualitative insights from patient experiences of SMART DAPPER interventions for major depression and traumatic stress disorders in Kenya. PLOS Glob Public Health. 2024 Sep 5;4(9):e0002685. doi: 10.1371/journal.pgph.0002685. eCollection 2024.
PubMed 39236052Levy R, Mathai M, Chatterjee P, Ongeri L, Njuguna S, Onyango D, Akena D, Rota G, Otieno A, Neylan TC, Lukwata H, Kahn JG, Cohen CR, Bukusi D, Aarons GA, Burger R, Blum K, Nahum-Shani I, McCulloch CE, Meffert SM. Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya. BMC Psychiatry. 2019 Dec 28;19(1):424. doi: 10.1186/s12888-019-2395-x.
PubMed 31883526
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential, Multiple Assignment Randomized Trial (SMART) for Non-specialist Treatment of Common Mental Disorders in Kenya: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research (DAPPER) Project
- ClinicalTrials.gov ID
- NCT03466346
- Acronym / sponsor ID
- SMART-DAPPER / 1R01MH115512 1R01MH113722-01A1
- Conditions
- Depression, Unipolar, Posttraumatic Stress Disorder, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,162 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Nairobi, National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of California, San Diego, Makerere University
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.
Detailed description
Mental disorders are a leading cause of global disability, driven by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Despite nearly 15 years of efficacy research showing that local non-specialists can provide evidence-based care for depression and anxiety in LMICs, few studies have advanced to the critical next step: identifying strategies for sustainable "real world" non-specialist treatment including integration with existing healthcare platforms and response to common clinical dilemmas, such as what treatment to start with and how to modify it.
Given the need to personalize treatment to achieve remission (absence of disease) and the scarcity of mental health specialists in LMICs, successful reduction of population-level disability caused by depression and anxiety requires (1) evidence-based strategies for first-line and second-line (non-remitter) treatment delivered by non-specialists, with (2) confirmation of presumed mechanism of action and (3) patient-level moderators of treatment outcome to inform personalized, non-specialist treatment algorithms.
The research team has worked in western Kenya for 6 years with a UCSF-Kenya collaboration that supports integrated HIV services at over 70 primary healthcare facilities in Kisumu County (Family AIDS Care and Education Services [FACES]). Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) (26%) and Posttraumatic Stress Disorder (PTSD) (35%). Kenyan leaders lack an evidence base for two essential treatments - psychotherapy and second generation antidepressants- without which scale-up will fall short of its potential. We conducted a randomized, controlled trial in Kisumu County of Interpersonal Psychotherapy (IPT) delivered by non-specialists for HIV-positive patients with MDD and PTSD. In our study, IPT achieved full remission of MDD and PTSD in the majority of participants.
Given the high prevalence of MDD-PTSD co-morbidity, we will collaborate with the FACES team providing services to Kisumu County Hospital (KCH) primary care outpatient clinic (~10,000 patients/month) to conduct a randomized trial of IPT versus fluoxetine for MDD and/or PTSD. Local non-specialists will be trained in mental health care for the SMART and hired through the Kenyan Ministry of Health to work at KCH. SMART participants will be randomized to: (1) first line treatment with IPT or fluoxetine; (2) second line treatment for non-remitters- treatment "switch" (e.g., IPT to fluoxetine) or treatment "combination" (e.g., addition of IPT to fluoxetine). Research with mental health specialists in high income countries suggests that antidepressants and psychotherapy have equivalent short-term efficacy and that psychotherapy yields superior long-term relapse prevention. We will test the role of previously identified mechanisms in mediating remission and key moderators of treatment effect. Results of moderator and Q learning analyses will produce first and second-line non-specialist treatment algorithms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- fluoxetine versus interpersonal psychotherapy (IPT) for treatment of Major Depressive Disorder (MDD) and/or Posttraumatic Stress Disorder (PTSD)
| Arm | Type | Receives |
|---|---|---|
| Interpersonal psychotherapy | Active comparator | Behavioral: Interpersonal PsychotherapyIPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area. |
| fluoxetine | Active comparator | Drug: FluoxetineFluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression. |
| Fluoxetine after IPT | Active comparator | Drug: Fluoxetineparticipants who do not remit from MDD and PTSD after treatment with IPT may be randomized to fluoxetine. |
| IPT after fluoxetine | Active comparator | Behavioral: Interpersonal Psychotherapyparticipants who do not remit from MDD and PTSD after treatment with fluoxetine may be randomized to IPT. |
| IPT + fluoxetine | Active comparator | Drug: Fluoxetine, Behavioral: Interpersonal Psychotherapyparticipants who do not remit from MDD and PTSD after treatment with fluoxetine may be randomized to IPT + fluoxetine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for depression and/or PTSD
- Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) 18 years or older
Key exclusion criteria (5 listed)
- Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation)
- acute suicidality requiring higher level of care
- drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher)
- history of mania or requiring treatment for hypomania
- Outside mental health treatment during the study treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team).
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 |
|---|---|---|
| FluoxetineFluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression. | Drug | Fluoxetine after IPT, IPT + fluoxetine, fluoxetine |
| Interpersonal PsychotherapyAlso: IPTIPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area. | Behavioural | IPT + fluoxetine, IPT after fluoxetine, Interpersonal psychotherapy |
Primary outcome
Number of Participants With Major Depression at End of Treatment
Time frame: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)
Number of Participants with Major Depression. The Beck Depression Inventory-Second Edition (BDI-II) was used and a score of 19 or greater was defined as positive for major depression. BDI-II score below 19 is defined as negative for major depression. Scores range from 0 to 63 with higher total scores indicating more severe depressive symptoms.
Number of Participants With PTSD
Time frame: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)
Number of Participants with PTSD. The PTSD Checklist for DSM-5 (PCL-5) was used and score of 23 or greater is defined as positive for PTSD. PCL-5 score below 23 is defined as negative for PTSD. Score range from 0 to 80 with higher total scores indicating more severe PTSD symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41184028Mwai D, Meffert SM, Olwanda EE, Mathai MA, Ongeri L, Burger RL, Mbwayo A, Rota G, Otieno A, Cohen CR, Bukusi D, Aarons GA, Neylan TC, McCulloch CE, Jin C, Akena D, Kahonge S, Kahn JG. Productivity benefits of treatment of depression and post-traumatic stress disorder in Kenya. BMJ Glob Health. 2025 Nov 3;10(11):e018204. doi: 10.1136/bmjgh-2024-018204.
- Derived from this study: PubMed 40854809Burger RL, Meffert SM meffert, Ongeri L, Wangia J, Wambura R, Ajore P, Rota G, Otieno A, Obura RR, Muchembre P, Bukusi D, Mbwayo A, Neylan TC, Akena D, Jin C, McCulloch C, Mathai MA. Factors associated with fluoxetine adherence among outpatients with common mental disorders in Western Kenya. BMJ Glob Health. 2025 Aug 25;10(8):e017929. doi: 10.1136/bmjgh-2024-017929.
- Derived from this study: PubMed 40766223Olwanda E, Mwai D, Mathai M, Burger R, Ongeri L, Bukusi D, Mbwayo A, Rota G, Otieno A, Rota R, Meffert S, Kahn JG. Cost-Benefit Analysis of Interpersonal Therapy and Fluoxetine for Treating Depression and PTSD in Primary Care Settings in Kenya. Res Sq [Preprint]. 2025 Jul 28:rs.3.rs-6977800. doi: 10.21203/rs.3.rs-6977800/v1.
- Derived from this study: PubMed 39557549Meffert S, Mathai M, Neylan T, Mwai D, Onyango DO, Rota G, Otieno A, Obura RR, Wangia J, Opiyo E, Muchembre P, Oluoch D, Wambura R, Mbwayo A, Kahn JG, Cohen CR, Bukusi D, Aarons GA, Burger RL, Jin C, McCulloch C, Kahonge S, Ongeri L. Preference of mHealth versus in-person treatment for depression and post-traumatic stress disorder in Kenya: demographic and clinical characteristics. BMJ Open. 2024 Nov 18;14(11):e083094. doi: 10.1136/bmjopen-2023-083094.
- Derived from this study: PubMed 39236052Getahun M, Mathai MA, Rota G, Allen A, Burger RL, Opiyo E, Oluoch D, Wangia J, Wambura R, Mbwayo A, Muchembre P, Obura RR, Neylan TC, Aarons GA, Ongeri L, Meffert SM. "The peace that I wanted, I got": Qualitative insights from patient experiences of SMART DAPPER interventions for major depression and traumatic stress disorders in Kenya. PLOS Glob Public Health. 2024 Sep 5;4(9):e0002685. doi: 10.1371/journal.pgph.0002685. eCollection 2024.
- Derived from this study: PubMed 31883526Levy R, Mathai M, Chatterjee P, Ongeri L, Njuguna S, Onyango D, Akena D, Rota G, Otieno A, Neylan TC, Lukwata H, Kahn JG, Cohen CR, Bukusi D, Aarons GA, Burger R, Blum K, Nahum-Shani I, McCulloch CE, Meffert SM. Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya. BMC Psychiatry. 2019 Dec 28;19(1):424. doi: 10.1186/s12888-019-2395-x.
- Individual participant dataSharing planned: Yes. NIMH Data Archive The National Institutes of Health (NIH) and NIMH have developed a federation of data repositories called the NIMH Data Archive (NDA) to store the collection of data from participants in research studies related to mental health, regardless of the source of funding. The extensive information collected by these studies, and subsequently stored in the National Database for Autism Research (NDAR), the NIH Pediatric MRI Repository (PedsMRI), the National Database for Clinical Trials Related to Mental Illness (NDCT), and the Research Domain Criteria Database (RDoCdb) provides a rare and valuable scientific resource. The NIH and the NIMH seek to encourage the use of these resources to achieve rapid scientific progress. In order to take full advantage of such resources and maximize their research value, it is important that data be made available, on appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner.
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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.
Muthoni J Mathai, MDChB, MMed principal investigator
University of Nairobi
Susan M Meffert, MD, MPH principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine and Interpersonal Psychotherapy in people with Depression, Unipolar and Posttraumatic Stress Disorder, run by University of California, San Francisco at 3 sites in Kenya.
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 2 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Major Depression at End of Treatment (time frame: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)). 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?
On the ClinicalTrials.gov record for NCT03466346, which also lists 6 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 2 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.