Trial Outcomes & Findings for ADAPT: Addressing Depression and Pain Together (NCT NCT01124188)
NCT ID: NCT01124188
Last Updated: 2017-05-12
Results Overview
The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry.
COMPLETED
PHASE4
263 participants
14 weeks
2017-05-12
Participant Flow
Participant milestones
| Measure |
Study Intervention Arm
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks.
|
Active Control
Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
71
|
|
Overall Study
COMPLETED
|
60
|
65
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ADAPT: Addressing Depression and Pain Together
Baseline characteristics by cohort
| Measure |
Study Intervention Arm
n=68 Participants
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks.
|
Active Control
n=71 Participants
Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Age, Continuous
|
70.81 years
STANDARD_DEVIATION 7.90 • n=99 Participants
|
69.90 years
STANDARD_DEVIATION 8.73 • n=107 Participants
|
70.34 years
STANDARD_DEVIATION 8.32 • n=206 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
68 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 weeksThe PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry.
Outcome measures
| Measure |
Study Intervention Arm
n=68 Participants
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks.
|
Active Control
n=71 Participants
Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
|
|---|---|---|
|
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
|
28 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksChange in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Improvement of 30% is clinically meaningful
Outcome measures
| Measure |
Study Intervention Arm
n=68 Participants
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks.
|
Active Control
n=71 Participants
Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
|
|---|---|---|
|
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
|
-3.67 units on a scale
Interval -4.88 to -2.46
|
-3.20 units on a scale
Interval -4.35 to -2.05
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksChange in SPPB scores from randomization to 14 weeks for both arms. The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance
Outcome measures
| Measure |
Study Intervention Arm
n=68 Participants
Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks.
|
Active Control
n=71 Participants
Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
|
|---|---|---|
|
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
|
0.49 units on a scale
Interval -0.06 to 1.03
|
0.54 units on a scale
Interval 0.06 to 1.02
|
Adverse Events
Study Intervention Arm
Active Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place