Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression
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|ClinicalTrials.gov Identifier: NCT01051440|
Recruitment Status : Terminated (Slow enrollment)
First Posted : January 18, 2010
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: Lisdexamfetamine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Magnetic Resonance Spectroscopy and fMRI Study of the Effects of Lisdexamfetamine on Bipolar Depression|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Placebo Comparator: Placebo
Subjects will receive placebo for lisdexamfetamine.
Subjects will receive placebo matched to lisdexamfetamine.
Active Comparator: Lisdexamfetamine
Subjects will start with 20 mg per day of lisdexamfetamine and may increase to a maximum of 40 mg.
Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.
Other Name: Vyvanse
- Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time. [ Time Frame: baseline and 8 weeks ]The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.
- Change in Clinical Global Impressions Severity (CGI-S) Score. [ Time Frame: baseline and week 8 ]The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of "normal, not at all ill" to 7 with an anchor of "among the most extremely ill patients". Thus, higher scores indicate greater severity of symptoms.
- Change in Clinical Global Impressions Improvement (CGI-I) Score. [ Time Frame: week 1 and week 9 ]The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051440
|United States, Massachusetts|
|Steward St. Elizabeth's Medical Center|
|Boston, Massachusetts, United States, 02135|
|Principal Investigator:||Michael E Henry, MD||Steward St. Elizabeth's Medical Center of Boston, Inc.|