Status:
TERMINATED
Stimulant Enhancement of Well-Being Therapy for Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Harvard Medical School (HMS and HSDM)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Outpatients between 18 and 60 years of age.
- 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.
- Fulfillment of DSM-IV diagnostic criteria for MDD during the present episode of illness with continuing residual symptoms.
- A score of 14 to 26 on the 31-item Hamilton Depression Rating Scale (HAM-D-31) at screening and randomization.
- A Clinical Global Impression of Severity (CGI-S) score of 3 or 4 at screening and randomization.
- Exclusion Criteria
- Treatment within 4 weeks of randomization with any non-SSRI antidepressant, antipsychotic, mood stabilizer, standing benzodiazepine, stimulant, or stimulant-like agent.
- Allowed exception 1: Concomitant benzodiazepines, at a stable dose, that have been taken for at least one year with no history of abuse.
- Allowed exception 2: Effexor, duloxetine (Cymbalta) or milnacipran (Savella) can serve as main SSRI treatment.
- Allowed exception 3: Combinations of SSRIs (ex. Zoloft \& Lexapro concomitantly) are acceptable as main SSRI treatment.
- 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.
- Significant suicide risk.
- Current treatment-resistant episode of MDD.
- A primary diagnosis of an Axis I disorder other than MDD.
- History of a psychotic disorder, dysthymia, antisocial personality disorder, BPD, or mental retardation.
- History of a substance use disorder, with the exception of nicotine dependence, within 12 months prior to screening.
- History of stimulant abuse, prescription drug abuse, and eating disorders.
- 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.
- 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.
- Allergy, hypersensitivity, intolerance, or history of non-responsivity to stimulant medications.
- History of non-responsivity to CBT or well-being therapy.
- Women who are pregnant or breastfeeding.
- Glaucoma or hyperthyroidism
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01478113
Start Date
February 1 2012
End Date
July 1 2015
Last Update
April 26 2017
Active Locations (1)
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1
Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114