Trial Outcomes & Findings for Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia (NCT NCT01851863)
NCT ID: NCT01851863
Last Updated: 2015-02-23
Results Overview
The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
262 participants
Primary outcome timeframe
weeks 1, 2, 4, 8
Results posted on
2015-02-23
Participant Flow
Participant milestones
| Measure |
Deanxit(Psychological and GI) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
65
|
66
|
|
Overall Study
COMPLETED
|
60
|
57
|
60
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
5
|
3
|
Reasons for withdrawal
| Measure |
Deanxit(Psychological and GI) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Overall Study
Did not receive study medication
|
2
|
5
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
2
|
3
|
Baseline Characteristics
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Baseline characteristics by cohort
| Measure |
Deanxit(Psychological and GI) + Omeprazole
n=65 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
n=66 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
n=65 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
n=66 Participants
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.69 years
STANDARD_DEVIATION 10.74 • n=39 Participants
|
44.16 years
STANDARD_DEVIATION 9.26 • n=41 Participants
|
45.72 years
STANDARD_DEVIATION 10.35 • n=35 Participants
|
46.81 years
STANDARD_DEVIATION 9.82 • n=31 Participants
|
45.91 years
STANDARD_DEVIATION 10.24 • n=146 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
143 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
31 Participants
n=31 Participants
|
119 Participants
n=146 Participants
|
|
Region of Enrollment
China
|
65 participants
n=39 Participants
|
66 participants
n=41 Participants
|
65 participants
n=35 Participants
|
66 participants
n=31 Participants
|
262 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: weeks 1, 2, 4, 8The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.
Outcome measures
| Measure |
Deanxit(Psychological and GI) + Omeprazole
n=65 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
n=66 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
n=65 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Compliance of Flupentixol-Melitracen
|
44 participants
|
28 participants
|
31 participants
|
—
|
SECONDARY outcome
Timeframe: week 0 and 8The severity of patients' dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and \> 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome.
Outcome measures
| Measure |
Deanxit(Psychological and GI) + Omeprazole
n=60 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
n=57 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
n=60 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
n=63 Participants
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8
|
-3.85 units on LDQ scale
Interval -9.0 to 2.0
|
-2.51 units on LDQ scale
Interval -8.0 to 3.0
|
-2.49 units on LDQ scale
Interval -6.0 to 3.0
|
-1.31 units on LDQ scale
Interval -7.0 to 2.0
|
SECONDARY outcome
Timeframe: week 0 and 8Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome.
Outcome measures
| Measure |
Deanxit(Psychological and GI) + Omeprazole
n=60 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
n=57 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
n=60 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
n=63 Participants
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8
HADS anxiety score
|
-4.46 units on HADS score
Interval -12.0 to 3.0
|
-2.29 units on HADS score
Interval -9.0 to 3.0
|
-2.78 units on HADS score
Interval -9.0 to 4.0
|
-1.68 units on HADS score
Interval -6.0 to 3.0
|
|
Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8
HADS depression score
|
-4.82 units on HADS score
Interval -10.0 to 2.0
|
-2.25 units on HADS score
Interval -7.0 to 5.0
|
-2.86 units on HADS score
Interval -9.0 to 4.0
|
-1.88 units on HADS score
Interval -6.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksNumber of participants with adverse reactions were recorded to analyze the safety profile of treatment.
Outcome measures
| Measure |
Deanxit(Psychological and GI) + Omeprazole
n=60 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
n=57 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
n=60 Participants
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
n=63 Participants
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Number of Participants With Adverse Reaction
|
6 participants
|
9 participants
|
5 participants
|
2 participants
|
Adverse Events
Deanxit(Psychological and GI) + Omeprazole
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Deanxit(Psychological) + Omeprazole
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Deanxit(Without Explanation) + Omeprazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Proton Pump Inhibitor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Deanxit(Psychological and GI) + Omeprazole
n=65 participants at risk
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
|
Deanxit(Psychological) + Omeprazole
n=66 participants at risk
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
|
Deanxit(Without Explanation) + Omeprazole
n=65 participants at risk
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
|
Proton Pump Inhibitor
n=66 participants at risk
Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
|
|---|---|---|---|---|
|
Nervous system disorders
Insomnia
|
4.6%
3/65
|
6.1%
4/66
|
6.2%
4/65
|
0.00%
0/66
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/65
|
0.00%
0/66
|
|
General disorders
Dry mouth
|
1.5%
1/65
|
3.0%
2/66
|
1.5%
1/65
|
0.00%
0/66
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/65
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/65
|
1.5%
1/66
|
Additional Information
Sheng-Liang Chen, MD
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China
Phone: 86-21-58752345
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place