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Stimulant Enhancement of Well-Being Therapy for Depression

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ClinicalTrials.gov Identifier: NCT01478113
Recruitment Status : Terminated (PI left the institution and was no funding to continue study.)
First Posted : November 23, 2011
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Maren Nyer, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Amphetamine/dextroamphetamine
Drug: Placebo
Behavioral: Well-being therapy
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 2 2
Completed 1 1
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             0             1
Physician Decision             1             0
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
50
(45 to 55)
54
(53 to 55)
52
(45 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
1
  50.0%
1
  25.0%
Male
2
 100.0%
1
  50.0%
3
  75.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2
 100.0%
2
 100.0%
4
 100.0%
1.Primary Outcome
Title Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items
Hide Description 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.
Time Frame Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item
Hide Description 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.
Time Frame Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title WBT + Amphetamine/Dextroamphetamine WBT + Placebo
Hide Arm/Group Description:

In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.

Amphetamine/dextroamphetamine: 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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Psychological Well-being Scale (PWB)
Hide Description Well-being improvement: Comparison between the 2 groups of changes on the PWB at Baseline and Visit 11/Early Termination.
Time Frame Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in the Snaith-Hamilton Pleasure Scale (SHAPS)
Hide Description Improvement of anhedonia: Comparison between the 2 groups of changes on the SHAPS at Baseline and Visit 11/Early Termination.
Time Frame Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title WBT + Amphetamine/Dextroamphetamine WBT + Placebo
Hide Arm/Group Description:

In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.

Amphetamine/dextroamphetamine: 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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Behavioral Inhibition/Activation Scale (BIS/BAS)
Hide Description Improvement of deficits in behavioral activation: Comparison between the 2 groups of changes on the BIS/BAS at Baseline and Visit 11/Early Termination.
Time Frame Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Positive and Negative Affective Scale (PANAS)
Hide Description Improvement of deficits in positive affectivity: Comparison between the 2 groups of changes on the PANAS at Baseline and Visit 11/Early Termination.
Time Frame Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Functioning on Short Form-12(SF-12)
Hide Description Functional improvement: Comparison between the 2 groups of changes on the SF-12 scale at Baseline and Visit 11/Early termination visit.
Time Frame Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.
Hide Outcome Measure Data
Hide Analysis Population Description
not able to analyze due to small sample size
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Well-being Therapy With Amphetamine/Dextroamphetamine Well-being Therapy With Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      0/2 (0.00%)    
Psychiatric disorders     
Insomnia and Headache *  1/2 (50.00%)  1 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
This study was shut down due to original PI leaving the institution and due to lack of continued funding. As such, we were not able to enroll a sufficient number of patients to analyze data/answer study hypothesis/achieve study aims.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maren Nyer
Organization: Massachusetts General Hospital
Phone: 617-643-4897
Responsible Party: Maren Nyer, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01478113     History of Changes
Other Study ID Numbers: 2011P002148
2011D002171 ( Other Grant/Funding Number: InfoED ID: Kaplen Fellowship and Livingston Award )
First Submitted: September 26, 2011
First Posted: November 23, 2011
Results First Submitted: January 17, 2017
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017