Stimulant Enhancement of Well-Being Therapy for Depression

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01478113
• Collaborator: Harvard Medical School (HMS and HSDM) (Other)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 40.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study aims to identify a novel enhancement strategy for residual symptoms of major depressive disorder (MDD) Dopamine (DA) has been viewed as a "pleasure neurotransmitter" for over 30 years. Yet recent data from animal and human studies suggest that dopamine has greater effects on "wanting" than on "liking." Therefore, the investigators of this study have hypothesized that amphetamine/d-amphetamine (AMPH), a medication which increases dopamine transmission in the reward centers of the brain, may have a more powerful antidepressant effect in combination with well-being therapy (WBT), a specific type of cognitive-behavioral therapy, which helps individuals with depression to increase their contact with natural rewards and decrease reward-interfering thoughts.

The investigators will test their hypothesis by randomizing 40 individuals with residual symptoms of depression, already taking an antidepressant that affects serotonin (e.g. Prozac, Paxil), to 8 weeks of treatment with either WBT in combination with AMPH, or WBT with pill placebo. The effectiveness of each treatment will be measured using a reliable scale, called the Hamilton Depression Rating Scale.

The investigators have also hypothesized that people assigned to the stimulant/WBT group will have greater improvements in functioning, well-being, and positive affectivity than those the people assigned to the WBT/placebo group.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Amphetamine/dextroamphetamine; Drug: Placebo; Behavioral: Well-being therapy	N/A

Detailed Description

The study will have 11 visits occur over 8 weeks with study visits scheduled weekly or biweekly.

Detailed Description:

The study visit occurrences are as follows:

1. Week 0- Screening Visit

2. Week 1- Baseline Visit

3. Week 2- one phone visit and one clinic visit in one week

4. Week 3- one phone visit and one clinic visit in one week

5. Week 4- one visit in one week

6. Week 5- one visit in one week

7. Week 6- one visit in one week

8. Week 7- one visit in one week

9. Week 8- one visit in one week

WBT description Four licensed therapists, who have been trained and certified in WBT, will provide weekly sessions of 30 to 50 minutes in duration. Therapists will follow the procedures outlined in the WBT manual. The initial sessions (weeks 0-2) will be focused on identifying and contextualizing episodes of well-being. The intermediate sessions (weeks 3-5) will be focused on modifying cognitions and behaviors, which lead to premature interruption of well-being, and optimizing cognitions and behaviors, which have been idiographically linked to enhanced well-being. Final sessions (weeks 6-8) will apply the Psychological Well-Being scales (PWB) to refine treatment according to Ryff's dimensions of well-being. Additional principles and techniques of WBT include reappraisal, mood-charting, scheduling of activities, shaping, problem-solving, and assertiveness training.

Medication Schedule Participants will receive treatment with the stimulant, amphetamine/d-amphetamine, or matched placebo.

Participants will start at 1 pill (placebo or 5 mg amphetamine/d-amphetamine) in the morning and 1 pill (placebo or 5 mg amphetamine/d-amphetamine) at noon. The treatment will then be flexibly adjusted up or down by a study clinician based on 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stimulant Enhancement of Well-Being Therapy for Depression
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: WBT + amphetamine/dextroamphetamine In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.	Drug: 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.; Other Names: Adderall Adderall XR ; Behavioral: Well-being therapy; Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.; Other Names: WBT
Placebo Comparator: WBT + placebo In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.	Drug: Placebo; The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.; Other Names: Sugar-pill ; Behavioral: Well-being therapy; Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.; Other Names: WBT

Outcome Measures

Primary Outcome Measures

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

   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.

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

   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.

Secondary Outcome Measures

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

   Well-being improvement: Comparison between the 2 groups of changes on the PWB at Baseline and Visit 11/Early Termination.

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

   Improvement of anhedonia: Comparison between the 2 groups of changes on the SHAPS at Baseline and Visit 11/Early Termination.

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

   Improvement of deficits in behavioral activation: Comparison between the 2 groups of changes on the BIS/BAS at Baseline and Visit 11/Early Termination.

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

   Improvement of deficits in positive affectivity: Comparison between the 2 groups of changes on the PANAS at Baseline and Visit 11/Early Termination.

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

   Functional improvement: Comparison between the 2 groups of changes on the SF-12 scale at Baseline and Visit 11/Early termination visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Outpatients between 18 and 60 years of age.

2. Experiencing residual symptoms after 8 weeks of SSRI therapy, with at least 4 weeks at a stable dose of the current agent prior to randomization.

3. Fulfillment of DSM-IV diagnostic criteria for MDD during the present episode of illness with continuing residual symptoms.

4. A score of 14 to 26 on the 31-item Hamilton Depression Rating Scale (HAM-D-31) at screening and randomization.

5. A Clinical Global Impression of Severity (CGI-S) score of 3 or 4 at screening and randomization.

Exclusion Criteria

1. Treatment within 4 weeks of randomization with any non-SSRI antidepressant, antipsychotic, mood stabilizer, standing benzodiazepine, stimulant, or stimulant-like agent.

2. Allowed exception 1: Concomitant benzodiazepines, at a stable dose, that have been taken for at least one year with no history of abuse.

3. Allowed exception 2: Effexor, duloxetine (Cymbalta) or milnacipran (Savella) can serve as main SSRI treatment.

4. Allowed exception 3: Combinations of SSRIs (ex. Zoloft & Lexapro concomitantly) are acceptable as main SSRI treatment.

5. If a subject endorses "yes" or "agree" of any item from 12 to 23 on the CHRT, it would indicate active suicidality and would be exclusionary.

6. Significant suicide risk.

7. Current treatment-resistant episode of MDD.

8. A primary diagnosis of an Axis I disorder other than MDD.

9. History of a psychotic disorder, dysthymia, antisocial personality disorder, BPD, or mental retardation.

10. History of a substance use disorder, with the exception of nicotine dependence, within 12 months prior to screening.

11. History of stimulant abuse, prescription drug abuse, and eating disorders.

12. Initial insomnia at screening that is not adequately controlled by medications. Subjects with recent history of unstable insomnia as defined by active or poorly controlled symptoms of insomnia within the past 1 month will be excluded.

13. Co-morbid medical conditions including a structural heart defect or rhythm abnormality that might be exacerbated by stimulant therapy; hypertension as measured by a resting sitting systolic blood pressure of > 149mmHg or diastolic blood pressure > 95mmHg; tachycardia as measured by a sitting pulse rate of >100 bpm or <50 bpm after resting for 5 minutes.

14. Allergy, hypersensitivity, intolerance, or history of non-responsivity to stimulant medications.

15. History of non-responsivity to CBT or well-being therapy.

16. Women who are pregnant or breastfeeding.

17. Glaucoma or hyperthyroidism

18. Current concomitant therapy is only permitted if it is supportive therapy (not specifically CBT) and has been ongoing for at least one year. However, if a subject has been in therapy for less than one year and wishes to discontinue or take a hiatus from their current therapy before coming in for a screening visit, this will be allowed. Additionally, subjects may not enter into other talk therapies for the duration of this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Depression Clinical and Research Program	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Harvard Medical School (HMS and HSDM)

Investigators

• Principal Investigator: Maurizio Fava, MD, Massachusetts General Hospital and Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maren Nyer, Clinical Psychologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01478113
• Other Study ID Numbers: 2011P002148; 2011D002171
• First Posted: Nov 23, 2011
• Last Update Posted: Apr 26, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Maren Nyer, Clinical Psychologist, Massachusetts General Hospital: Major Depressive Disorder; Therapy; Medication study; Depression; Therapy study
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Amphetamine; Adderall; Dextroamphetamine

Study Results

Participant Flow

Arm/Group Title	Well-being Therapy With Amphetamine/Dextroamphetamine	Well-being Therapy With Placebo
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

Baseline Characteristics

Arm/Group Title	Well-being Therapy With Amphetamine/Dextroamphetamine	Well-being Therapy With Placebo	Total
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 Participants	2	2	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	2 100%	4 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	50	54	52
Sex: Female, Male (Count of Participants)
Female	0 0%	1 50%	1 25%
Male	2 100%	1 50%	3 75%
Region of Enrollment (Count of Participants)
United States	2 100%	2 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items
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.

Outcome Measure Data

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
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.
Measure Participants	0	0

2. Primary Outcome

Title	Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item
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.

Outcome Measure Data

Analysis Population Description

not able to analyze due to small sample size

Arm/Group Title	WBT + Amphetamine/Dextroamphetamine	WBT + Placebo
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.
Measure Participants	0	0

3. Secondary Outcome

Title	Change in Psychological Well-being Scale (PWB)
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.

Outcome Measure Data

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
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.
Measure Participants	0	0

4. Secondary Outcome

Title	Change in the Snaith-Hamilton Pleasure Scale (SHAPS)
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.

Outcome Measure Data

Analysis Population Description

not able to analyze due to small sample size

Arm/Group Title	WBT + Amphetamine/Dextroamphetamine	WBT + Placebo
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.
Measure Participants	0	0

5. Secondary Outcome

Title	Change in Behavioral Inhibition/Activation Scale (BIS/BAS)
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.

Outcome Measure Data

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
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.
Measure Participants	0	0

6. Secondary Outcome

Title	Change in Positive and Negative Affective Scale (PANAS)
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.

Outcome Measure Data

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
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.
Measure Participants	0	0

7. Secondary Outcome

Title	Change in Functioning on Short Form-12(SF-12)
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.

Outcome Measure Data

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
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.
Measure Participants	0	0

Adverse Events

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.
Arm/Group Title	Well-being Therapy With Amphetamine/Dextroamphetamine		Well-being Therapy With Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
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%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Well-being Therapy With Amphetamine/Dextroamphetamine		Well-being Therapy With Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/2 (0%)
Psychiatric disorders
Insomnia and Headache	1/2 (50%)	1	0/2 (0%)	0

Limitations/Caveats

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

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.