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Major Depressive Disorder | Stimulant Enhancement of Well-Being Therapy for Depression

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Amphetamine/dextroamphetamineThe 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.

Drug:PlaceboThe placebo will match the dextroamphetamine in form, dosage, frequency, and duration.

Behavioral:Well-being therapyTherapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

WBT + amphetamine/dextroamphetamineIn the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.

WBT + placeboIn the placebo group, participants will receive treatment with Well-being therapy and pill placebo.

Study Status

Terminated

Start Date: February 2012

Completed Date: July 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items

Secondary Outcome: Change in Psychological Well-being Scale (PWB)

Study sponsors, principal investigator, and references

Principal Investigator: Maurizio Fava, MD

Lead Sponsor: Massachusetts General Hospital

Collaborator: Harvard Medical School

More information:https://clinicaltrials.gov/show/NCT01478113

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