Stimulant Enhancement of Well-Being Therapy for Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | February 2012 |
| End Date: | January 2014 |
| Contact: | Max Martinson, BS |
| Email: | mmartinson@partners.org |
| Phone: | 617-726-8727 |
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.
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.
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.
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.
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.
1. Allowed exception 1: Concomitant benzodiazepines, at a stable dose, that have
been taken for at least one year with no history of abuse.
2. Allowed exception 2: Effexor, duloxetine (Cymbalta) or milnacipran (Savella) can
serve as main SSRI treatment.
3. Allowed exception 3: Combinations of SSRIs (ex. Zoloft & Lexapro concomitantly)
are acceptable as main SSRI treatment.
2. 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.
3. Significant suicide risk.
4. Current treatment-resistant episode of MDD.
5. A primary diagnosis of an Axis I disorder other than MDD.
6. History of a psychotic disorder, dysthymia, antisocial personality disorder, BPD, or
mental retardation.
7. History of a substance use disorder, with the exception of nicotine dependence,
within 12 months prior to screening.
8. History of stimulant abuse, prescription drug abuse, and eating disorders.
9. 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.
10. 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.
11. Allergy, hypersensitivity, intolerance, or history of non-responsivity to stimulant
medications.
12. History of non-responsivity to CBT or well-being therapy.
13. Women who are pregnant or breastfeeding.
14. Glaucoma or hyperthyroidism
15. 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.
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