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NCT01478113 · ClinicalTrials.gov registry record · NA
Stimulant Enhancement of Well-Being Therapy for Depression
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01478113: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT01478113 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478113, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Amphetamine/dextroamphetamine
- BEHAVIORAL Well-being therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-07 |
| Phase | NA |
Why NCT01478113 stopped before completion
NCT01478113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01478113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478113 about?
NCT01478113 is a clinical study titled "Stimulant Enhancement of Well-Being Therapy for Depression". 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" tha...
What is the current status of trial NCT01478113?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2012-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01478113?
The interventions under investigation include: Placebo (DRUG), Amphetamine/dextroamphetamine (DRUG), Well-being therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01478113?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478113's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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