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Stimulant Enhancement of Well-Being Therapy for Depression

This study has been terminated.
(PI left the institution and was no funding to continue study.)
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Maren Nyer, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01478113
First received: September 26, 2011
Last updated: March 16, 2017
Last verified: March 2017
Results First Received: January 17, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Well-being Therapy With Amphetamine/Dextroamphetamine   Well-being Therapy With Placebo
STARTED   2   2 
COMPLETED   1   1 
NOT COMPLETED   1   1 
Withdrawal by Subject                0                1 
Physician Decision                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Well-being Therapy With Amphetamine/Dextroamphetamine   Well-being Therapy With Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 50 
 (45 to 55) 
 54 
 (53 to 55) 
 52 
 (45 to 55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  50.0%      1  25.0% 
Male      2 100.0%      1  50.0%      3  75.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items   [ Time Frame: Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit. ]

2.  Primary:   Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item   [ Time Frame: Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit. ]

3.  Secondary:   Change in Psychological Well-being Scale (PWB)   [ Time Frame: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit. ]

4.  Secondary:   Change in the Snaith-Hamilton Pleasure Scale (SHAPS)   [ Time Frame: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit. ]

5.  Secondary:   Change in Behavioral Inhibition/Activation Scale (BIS/BAS)   [ Time Frame: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit. ]

6.  Secondary:   Change in Positive and Negative Affective Scale (PANAS)   [ Time Frame: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit. ]

7.  Secondary:   Change in Functioning on Short Form-12(SF-12)   [ Time Frame: Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: mnyer@partners.org



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 )
Study First Received: September 26, 2011
Results First Received: January 17, 2017
Last Updated: March 16, 2017