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NCT01148979 · ClinicalTrials.gov registry record · Phase 4
Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.
A Phase 4 study of Major Depressive Disorder, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01148979: Completed Phase 4 study of Major Depressive Disorder, sponsored by Mclean Hospital.
NCT01148979 is a Phase 4 study of Major Depressive Disorder that has completed, run by Mclean Hospital. The registered enrollment target is 35 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01148979, a Phase 4 study of Major Depressive Disorder, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who are undergoing treatment with, but have only partially responded to, a selective-serotonin reuptake inhibitor (SSRI) or selective-norepinephrine reuptake inhibitor (SNRI) antidepressant. Specifically, the investigators hypothesize that symptoms potentially related to deficient dopaminergic activity, such as lassitude, apathy, reduced positive affect and impaired executive function, in particular, will improve. This protocol is designed to test the hypothesis that this cluster of co-occurring residual symptoms sometimes found in treated depression will respond as a group to adjunctive psychostimulant therapy. The investigators propose to demonstrate this cluster of residual depressive symptoms and to measure the effect of stimulant therapy on it. The investigators hope to better understand the specific symptoms in this clinical population that are likely to improve with stimulant therapy.
Primary Outcome
The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lisdexamfetamine Dimesylate (Vyvanse)
Study Locations (1)
Massachusetts
- McLean Hospital - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 4 |
What the finished NCT01148979 record still lists
NCT01148979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01148979 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01148979 about?
NCT01148979 is a clinical study titled "Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.". This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who are undergoing treatment with, but have only partially responded to, a selective-serotonin reuptake inhibitor (SS...
What is the current status of trial NCT01148979?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2010-09. Estimated completion is 2014-10.
What conditions does trial NCT01148979 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01148979?
The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine Dimesylate (Vyvanse) (DRUG).
Who is sponsoring clinical trial NCT01148979?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01148979 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01148979's enrollment target sits among peer trials
35 214th of 282 higher than 68 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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