Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression
|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|
|Primary Completion Date :||June 2011|
|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.
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.|