Trial Outcomes & Findings for Stimulant Enhancement of Well-Being Therapy for Depression (NCT NCT01478113)
NCT ID: NCT01478113
Last Updated: 2017-04-26
Results Overview
Comparison between the 2 groups of the percentage of subjects in remission, as defined by a HAM-D-17 score of \< 8 at endpoint visit 11/week 8 of treatment, or early termination visit.
TERMINATED
NA
5 participants
Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.
2017-04-26
Participant Flow
Participant milestones
| Measure |
Well-being Therapy With Amphetamine/Dextroamphetamine
In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
Well-being Therapy With Placebo
In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Well-being Therapy With Amphetamine/Dextroamphetamine
In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
Well-being Therapy With Placebo
In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Stimulant Enhancement of Well-Being Therapy for Depression
Baseline characteristics by cohort
| Measure |
Well-being Therapy With Amphetamine/Dextroamphetamine
n=2 Participants
In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
Well-being Therapy With Placebo
n=2 Participants
In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
54 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.Population: not able to analyze due to small sample size
Comparison between the 2 groups of the percentage of subjects in remission, as defined by a HAM-D-17 score of \< 8 at endpoint visit 11/week 8 of treatment, or early termination visit.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit.Population: not able to analyze due to small sample size
Comparison between the 2 groups of the percentage of participants who have responded to the treatment (response is defined here as a 50% or greater improvement on the HAM-D-31 score) between Baseline and Visit 11 or Early Termination Visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.Population: not able to analyze due to small sample size
Well-being improvement: Comparison between the 2 groups of changes on the PWB at Baseline and Visit 11/Early Termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.Population: not able to analyze due to small sample size
Improvement of anhedonia: Comparison between the 2 groups of changes on the SHAPS at Baseline and Visit 11/Early Termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.Population: not able to analyze due to small sample size
Improvement of deficits in behavioral activation: Comparison between the 2 groups of changes on the BIS/BAS at Baseline and Visit 11/Early Termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.Population: not able to analyze due to small sample size
Improvement of deficits in positive affectivity: Comparison between the 2 groups of changes on the PANAS at Baseline and Visit 11/Early Termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.Population: not able to analyze due to small sample size
Functional improvement: Comparison between the 2 groups of changes on the SF-12 scale at Baseline and Visit 11/Early termination visit.
Outcome measures
Outcome data not reported
Adverse Events
Well-being Therapy With Amphetamine/Dextroamphetamine
Well-being Therapy With Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Well-being Therapy With Amphetamine/Dextroamphetamine
n=2 participants at risk
In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
Well-being Therapy With Placebo
n=2 participants at risk
In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
|
|---|---|---|
|
Psychiatric disorders
Insomnia and Headache
|
50.0%
1/2 • Number of events 1 • Over the course of participant enrollment in the study (at each visit between Baseline and Visit 11), the total duration of which was 8 weeks.
|
0.00%
0/2 • Over the course of participant enrollment in the study (at each visit between Baseline and Visit 11), the total duration of which was 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place