Trial Outcomes & Findings for SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project (NCT NCT03466346)
NCT ID: NCT03466346
Last Updated: 2025-12-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2162 participants
Primary outcome timeframe
End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)
Results posted on
2025-12-02
Participant Flow
N=1682 Screened Out for =\>1 reason/ppt * 384 Didn't return -956 MDE- \& PTSD- * 179 Drug or Alcohol Use * 120 Suicidality * 100 Unwilling to ppt * 133 History/Current Mania * 82 Pregnant or Breastfeeding * 13 Taking FLX * 1 Age \<18 * 2 Didn't consent * 2 Current ppt * 6 Cognitive dysfunction N= 20 Eligible and Not Randomized for =\>1 reason/ppt * 6 Declined * 7 Specialized or Higher level of care * 2 Moved out * 2 Pregnant or breastfeeding * 2 Drug or Alcohol Use * 1 Boarding school
Participant milestones
| Measure |
Stage 1: Interpersonal Psychotherapy
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.
Interpersonal Psychotherapy: 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.
|
Stage 1: Fluoxetine
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.
Fluoxetine: 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.
|
Stage 2: IPT After Fluoxetine
Participants who did not remit with fluoxetine and were randomized to receive second line treatment with IPT
|
Stage 2: Fluoxetine After IPT
Participants who did not remit with IPT and were randomized to receive second line treatment with fluoxetine.
|
Stage 2: IPT and Fluoxetine
Combination treatment with both IPT and fluoxetine for participants who did not remit with IPT or fluoxetine
|
|---|---|---|---|---|---|
|
Stage 1 - 1st Line Trt (IPT or FLX)
STARTED
|
1082
|
1080
|
0
|
0
|
0
|
|
Stage 1 - 1st Line Trt (IPT or FLX)
COMPLETED
|
986
|
878
|
0
|
0
|
0
|
|
Stage 1 - 1st Line Trt (IPT or FLX)
NOT COMPLETED
|
96
|
202
|
0
|
0
|
0
|
|
Stage 2 - 2nd Line Trt (Combo or Switch)
STARTED
|
0
|
0
|
68
|
104
|
160
|
|
Stage 2 - 2nd Line Trt (Combo or Switch)
COMPLETED
|
0
|
0
|
50
|
77
|
109
|
|
Stage 2 - 2nd Line Trt (Combo or Switch)
NOT COMPLETED
|
0
|
0
|
18
|
27
|
51
|
Reasons for withdrawal
| Measure |
Stage 1: Interpersonal Psychotherapy
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.
Interpersonal Psychotherapy: 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.
|
Stage 1: Fluoxetine
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.
Fluoxetine: 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.
|
Stage 2: IPT After Fluoxetine
Participants who did not remit with fluoxetine and were randomized to receive second line treatment with IPT
|
Stage 2: Fluoxetine After IPT
Participants who did not remit with IPT and were randomized to receive second line treatment with fluoxetine.
|
Stage 2: IPT and Fluoxetine
Combination treatment with both IPT and fluoxetine for participants who did not remit with IPT or fluoxetine
|
|---|---|---|---|---|---|
|
Stage 1 - 1st Line Trt (IPT or FLX)
Death
|
0
|
3
|
0
|
0
|
0
|
|
Stage 1 - 1st Line Trt (IPT or FLX)
Physician Decision
|
12
|
26
|
0
|
0
|
0
|
|
Stage 1 - 1st Line Trt (IPT or FLX)
Participant withdrawal or relocated
|
15
|
31
|
0
|
0
|
0
|
|
Stage 1 - 1st Line Trt (IPT or FLX)
Lost to Follow-up
|
69
|
142
|
0
|
0
|
0
|
|
Stage 2 - 2nd Line Trt (Combo or Switch)
Physician Decision
|
0
|
0
|
2
|
1
|
4
|
|
Stage 2 - 2nd Line Trt (Combo or Switch)
Participant withdrawal or relocated
|
0
|
0
|
0
|
2
|
2
|
|
Stage 2 - 2nd Line Trt (Combo or Switch)
Lost to Follow-up
|
0
|
0
|
16
|
24
|
45
|
Baseline Characteristics
Partnered participants
Baseline characteristics by cohort
| Measure |
Stage 1: Fluoxetine
n=1080 Participants
6 months of fluoxetine. Participants began with 20mg 1 tablet per day. If symptom reduction did not occur, the dose was increased by 20mg increments each month to an upper limit of 60mg.
|
Stage 2: Fluoxetine After IPT
Participants who were not in remission after IPT who received second line treatment with fluoxetine
|
Stage 2: IPT After Fluoxetine
Participants who were not in remission after fluoxetine who received second line treatment with IPT
|
Stage 2: Fluoxetine and IPT
Participants who were not in remission after IPT or fluoxetine who received second line treatment with fluoxetine and IPT
|
Total
n=2162 Participants
Total of all reporting groups
|
Stage 1: Interpersonal Psychotherapy (IPT)
n=1082 Participants
3 months of weekly IPT sessions
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 10.8 • n=1080 Participants
|
—
|
—
|
—
|
35.7 years
STANDARD_DEVIATION 11 • n=2162 Participants
|
36 years
STANDARD_DEVIATION 11.2 • n=1082 Participants
|
|
Sex: Female, Male
Female
|
981 Participants
n=1080 Participants
|
—
|
—
|
—
|
1958 Participants
n=2162 Participants
|
977 Participants
n=1082 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=1080 Participants
|
—
|
—
|
—
|
204 Participants
n=2162 Participants
|
105 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1080 Participants
|
—
|
—
|
—
|
0 Participants
n=2162 Participants
|
0 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1080 Participants
|
—
|
—
|
—
|
0 Participants
n=2162 Participants
|
0 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1080 Participants
|
—
|
—
|
—
|
0 Participants
n=2162 Participants
|
0 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1080 Participants
n=1080 Participants
|
—
|
—
|
—
|
2162 Participants
n=2162 Participants
|
1082 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1080 Participants
|
—
|
—
|
—
|
0 Participants
n=2162 Participants
|
0 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1080 Participants
|
—
|
—
|
—
|
0 Participants
n=2162 Participants
|
0 Participants
n=1082 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1080 Participants
|
—
|
—
|
—
|
0 Participants
n=2162 Participants
|
0 Participants
n=1082 Participants
|
|
Region of Enrollment
Kenya
|
1080 participants
n=1080 Participants
|
—
|
—
|
—
|
2126 participants
n=2162 Participants
|
1082 participants
n=1082 Participants
|
|
Major Depression on Mini International Neuropsychiatric Interview (MINI)
|
1036 Participants
n=1080 Participants
|
—
|
—
|
—
|
2071 Participants
n=2162 Participants
|
1035 Participants
n=1082 Participants
|
|
PTSD (Mini International Neuropsychiatric Interview (MINI)
|
563 Participants
n=1080 Participants
|
—
|
—
|
—
|
1118 Participants
n=2162 Participants
|
555 Participants
n=1082 Participants
|
|
Major Depression adn PTSD (MINI)
|
519 Participants
n=1080 Participants
|
—
|
—
|
—
|
1027 Participants
n=2162 Participants
|
508 Participants
n=1082 Participants
|
|
Depression symptoms (BDI2)
|
29.1 BDI2 cutscore 19 for major depressio
STANDARD_DEVIATION 10.5 • n=1080 Participants
|
—
|
—
|
—
|
28.9 BDI2 cutscore 19 for major depressio
STANDARD_DEVIATION 10.4 • n=2162 Participants
|
28.7 BDI2 cutscore 19 for major depressio
STANDARD_DEVIATION 10.3 • n=1082 Participants
|
|
PTSD symptoms (PCL)
|
43.3 PCL-5 cutscore 23 for PTSD
STANDARD_DEVIATION 17.2 • n=1080 Participants
|
—
|
—
|
—
|
43.5 PCL-5 cutscore 23 for PTSD
STANDARD_DEVIATION 17.3 • n=2162 Participants
|
43.6 PCL-5 cutscore 23 for PTSD
STANDARD_DEVIATION 17.4 • n=1082 Participants
|
|
HIV co-morbidity
|
413 Participants
n=1080 Participants
|
—
|
—
|
—
|
851 Participants
n=2162 Participants
|
438 Participants
n=1082 Participants
|
|
Other co-morbidity (hypertension, diabetes, tuberculosis, syphilis, hypothyroidism, hyperthyroidism)
|
96 Participants
n=1080 Participants
|
—
|
—
|
—
|
195 Participants
n=2162 Participants
|
99 Participants
n=1082 Participants
|
|
History of Mental Health Care
|
13 Participants
n=1080 Participants
|
—
|
—
|
—
|
23 Participants
n=2162 Participants
|
10 Participants
n=1082 Participants
|
|
Lifetime physical intimate partner violence among partnered participants
|
343 Participants
n=568 Participants • Partnered participants
|
—
|
—
|
—
|
662 Participants
n=1119 Participants • Partnered participants
|
319 Participants
n=551 Participants • Partnered participants
|
PRIMARY outcome
Timeframe: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)Population: Number of participants with Major Depression in each arm at the end of 1st line Treatment (Stage 1) and the end of 2nd line Treatment (Stage 2)
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.
Outcome measures
| Measure |
Stage 1: Interpersonal Psychotherapy (IPT)
n=986 Participants
3 months of weekly IPT sessions
|
Stage 1: Fluoxetine
n=878 Participants
6 months of fluoxetine. Participants began with 20mg 1 tablet per day. If symptom reduction did not occur, the dose was increased by 20mg increments each month to an upper limit of 60mg.
|
Stage 2: Fluoxetine After IPT
n=77 Participants
Participants who were not in remission after IPT who received second line treatment with fluoxetine
|
Stage 2: IPT After Fluoxetine
n=50 Participants
Participants who were not in remission after fluoxetine who received second line treatment with IPT
|
Stage 2: Fluoxetine and IPT
n=109 Participants
Participants who were not in remission after IPT or fluoxetine who received second line treatment with fluoxetine and IPT
|
|---|---|---|---|---|---|
|
Number of Participants With Major Depression at End of Treatment
|
127 Participants
|
89 Participants
|
6 Participants
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)Population: Number of participants with PTSD in each arm at end of 1st line Treatment (Stage 1) and end of 2nd line Treatment (Stage 2)
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.
Outcome measures
| Measure |
Stage 1: Interpersonal Psychotherapy (IPT)
n=986 Participants
3 months of weekly IPT sessions
|
Stage 1: Fluoxetine
n=878 Participants
6 months of fluoxetine. Participants began with 20mg 1 tablet per day. If symptom reduction did not occur, the dose was increased by 20mg increments each month to an upper limit of 60mg.
|
Stage 2: Fluoxetine After IPT
n=77 Participants
Participants who were not in remission after IPT who received second line treatment with fluoxetine
|
Stage 2: IPT After Fluoxetine
n=50 Participants
Participants who were not in remission after fluoxetine who received second line treatment with IPT
|
Stage 2: Fluoxetine and IPT
n=109 Participants
Participants who were not in remission after IPT or fluoxetine who received second line treatment with fluoxetine and IPT
|
|---|---|---|---|---|---|
|
Number of Participants With PTSD
|
173 Participants
|
108 Participants
|
10 Participants
|
14 Participants
|
20 Participants
|
Adverse Events
Stage 1: Interpersonal Psychotherapy (IPT)
Serious events: 37 serious events
Other events: 326 other events
Deaths: 7 deaths
Stage 1: Fluoxetine
Serious events: 49 serious events
Other events: 139 other events
Deaths: 14 deaths
Stage 2: IPT After Fluoxetine
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Stage 2: Fluoxetine After IPT
Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths
Stage 2: Fluoxetine and IPT
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: Interpersonal Psychotherapy (IPT)
n=1082 participants at risk
3 months of weekly Interpersonal Psychotherapy sessions
|
Stage 1: Fluoxetine
n=1080 participants at risk
6 months of fluoxetine. Participants began with 20mg 1 tablet per day. If symptom reduction did not occur, the dose was increased by 20mg increments each month to an upper limit of 60mg.
|
Stage 2: IPT After Fluoxetine
n=68 participants at risk
Participants who did not remit with fluoxetine and were randomized to receive second line treatment with IPT
|
Stage 2: Fluoxetine After IPT
n=104 participants at risk
Participants who did not remit with IPT and were randomized to receive second line treatment with fluoxetine
|
Stage 2: Fluoxetine and IPT
n=160 participants at risk
IPT or fluoxetine participants who are not in remission at the end of first line treatment who receive IPT and fluoxetine (combination) as second line treatment
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal distress
|
0.09%
1/1082 • 30 month follow-up
|
0.46%
5/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Reproductive system and breast disorders
Ob/gyn
|
0.46%
5/1082 • 30 month follow-up
|
0.46%
5/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Fatigue/Malaise
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Ear and labyrinth disorders
Ear Nose and Throat (ENT)
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Investigations
Abnormal laboratory result
|
0.18%
2/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (MS)
|
0.18%
2/1082 • 30 month follow-up
|
0.37%
4/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
General disorders
Other SAEs
|
0.37%
4/1082 • 30 month follow-up
|
1.2%
13/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
1.9%
2/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Pain
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Infections and infestations
Typhoid
|
0.18%
2/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Injury, poisoning and procedural complications
Injury
|
0.18%
2/1082 • 30 month follow-up
|
0.28%
3/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.28%
3/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
Infections and infestations
Malaria
|
0.28%
3/1082 • 30 month follow-up
|
0.28%
3/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
1.9%
2/104 • 30 month follow-up
|
2.5%
4/160 • 30 month follow-up
|
|
General disorders
Dysphagia / odynophagia
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Cardiac disorders
Cardiovascular (CV)
|
0.09%
1/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Psychiatric disorders
Thought of self-harm or suicidal ideation
|
0.55%
6/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
Endocrine disorders
Endocrine/Metabolic
|
0.00%
0/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Blood and lymphatic system disorders
Hemopoietic sysytem
|
0.09%
1/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Infections and infestations
bacterial/fungal infection
|
0.00%
0/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Jaundice
|
0.00%
0/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Nervous system disorders
Neurological
|
0.09%
1/1082 • 30 month follow-up
|
0.28%
3/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Renal and urinary disorders
Renal system
|
0.00%
0/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
General disorders
Sexual dysfunction
|
0.00%
0/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
Other adverse events
| Measure |
Stage 1: Interpersonal Psychotherapy (IPT)
n=1082 participants at risk
3 months of weekly Interpersonal Psychotherapy sessions
|
Stage 1: Fluoxetine
n=1080 participants at risk
6 months of fluoxetine. Participants began with 20mg 1 tablet per day. If symptom reduction did not occur, the dose was increased by 20mg increments each month to an upper limit of 60mg.
|
Stage 2: IPT After Fluoxetine
n=68 participants at risk
Participants who did not remit with fluoxetine and were randomized to receive second line treatment with IPT
|
Stage 2: Fluoxetine After IPT
n=104 participants at risk
Participants who did not remit with IPT and were randomized to receive second line treatment with fluoxetine
|
Stage 2: Fluoxetine and IPT
n=160 participants at risk
IPT or fluoxetine participants who are not in remission at the end of first line treatment who receive IPT and fluoxetine (combination) as second line treatment
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.1%
12/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
1.2%
2/160 • 30 month follow-up
|
|
Investigations
Abnormal Laboratory Results
|
0.09%
1/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Psychiatric disorders
Thoughts of self-harm
|
0.55%
6/1082 • 30 month follow-up
|
0.28%
3/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Injury, poisoning and procedural complications
Burn
|
0.28%
3/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Cardiac disorders
Cardiovascular
|
0.74%
8/1082 • 30 month follow-up
|
0.56%
6/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Cardiac disorders
Chest pain
|
1.4%
15/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
12/1082 • 30 month follow-up
|
0.56%
6/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
General disorders
Dizziness
|
0.09%
1/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
Ear and labyrinth disorders
Ear Nose and Throat
|
1.0%
11/1082 • 30 month follow-up
|
0.46%
5/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Endocrine disorders
Endocrine/Metabolic
|
0.18%
2/1082 • 30 month follow-up
|
0.37%
4/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Fatigue/Malaise
|
0.65%
7/1082 • 30 month follow-up
|
0.56%
6/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Fever
|
0.37%
4/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Gastrointestinal disorders
Gastrointestinal Distress
|
0.92%
10/1082 • 30 month follow-up
|
1.6%
17/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Renal and urinary disorders
Genitourinary (GU)
|
0.65%
7/1082 • 30 month follow-up
|
0.37%
4/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Headache
|
3.1%
34/1082 • 30 month follow-up
|
0.46%
5/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
General disorders
Hemopoietic System
|
0.09%
1/1082 • 30 month follow-up
|
0.37%
4/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Infections and infestations
Infection - bacterial/fungal
|
0.00%
0/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Injury, poisoning and procedural complications
Injury
|
0.92%
10/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
Gastrointestinal disorders
Jaundice
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Infections and infestations
Malaria
|
5.2%
56/1082 • 30 month follow-up
|
1.4%
15/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
1.2%
2/160 • 30 month follow-up
|
|
General disorders
Miscellaneous
|
1.8%
20/1082 • 30 month follow-up
|
1.3%
14/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
1.9%
2/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.5%
27/1082 • 30 month follow-up
|
0.37%
4/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
Nervous system disorders
Neurological
|
0.28%
3/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Reproductive system and breast disorders
OBGYN
|
0.28%
3/1082 • 30 month follow-up
|
0.56%
6/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Pain
|
3.1%
34/1082 • 30 month follow-up
|
0.56%
6/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.62%
1/160 • 30 month follow-up
|
|
General disorders
Pallor
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.96%
1/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Renal and urinary disorders
Renal System
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
2.3%
25/1082 • 30 month follow-up
|
0.74%
8/1080 • 30 month follow-up
|
1.5%
1/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
3.1%
5/160 • 30 month follow-up
|
|
General disorders
Sedation
|
0.00%
0/1082 • 30 month follow-up
|
0.28%
3/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Seizure
|
0.00%
0/1082 • 30 month follow-up
|
0.19%
2/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Sexual Disfunction
|
0.00%
0/1082 • 30 month follow-up
|
0.09%
1/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Skin and subcutaneous tissue disorders
Skin
|
0.65%
7/1082 • 30 month follow-up
|
0.46%
5/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Sweating
|
0.00%
0/1082 • 30 month follow-up
|
0.46%
5/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
General disorders
Thyroid
|
0.09%
1/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
|
Infections and infestations
Typhoid
|
0.28%
3/1082 • 30 month follow-up
|
0.00%
0/1080 • 30 month follow-up
|
0.00%
0/68 • 30 month follow-up
|
0.00%
0/104 • 30 month follow-up
|
0.00%
0/160 • 30 month follow-up
|
Additional Information
Susan Meffert MD, MPH; Professor of Psychiatry; MPI
University of California San Francisco
Phone: 4158765455
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place