Trial Outcomes & Findings for Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression (NCT NCT01051440)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2013-01-30

Participant Flow

The recruitment period began in June 2010 and concluded in early 2012. Recruitment was through media advertisements and patients in the hospital outpatient clinic. Out of hundreds of individuals who were pre-screened by telephone, 31 were invited to the clinic for screening visits.

Participants who were not on an approved mood stabilizer (lithium, valproate, or lamotrigine) at the time of enrollment were eligible for a one-month lead in to start a mood stabilizer prior to randomization. Several participants were excluded due to psychiatric co-morbidity, unclear diagnosis, history of stimulant use, or medical concerns.

Participant milestones

Participant milestones
Measure	Placebo Subjects received matched placebo for lisdexamfetamine.	Lisdexamfetamine Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants Subjects received matched placebo for lisdexamfetamine.	Lisdexamfetamine n=1 Participants Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38 years STANDARD_DEVIATION 0 • n=5 Participants	30 years STANDARD_DEVIATION 0 • n=7 Participants	34 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: All participants randomized to lisdexamfetamine or placebo were included.

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Subjects received matched placebo for lisdexamfetamine.	Lisdexamfetamine n=1 Participants Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.	4 units on a scale 0	-22 units on a scale 0

SECONDARY outcome

Timeframe: baseline and week 8

Population: All participants who were randomized to lisdexamfetamine or placebo were included.

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Subjects received matched placebo for lisdexamfetamine.	Lisdexamfetamine n=1 Participants Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
Change in Clinical Global Impressions Severity (CGI-S) Score.	1 units on a scale	-2 units on a scale

SECONDARY outcome

Timeframe: week 1 and week 9

Population: All participants who were randomized to lisdexamfetamine or placebo were included.

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Subjects received matched placebo for lisdexamfetamine.	Lisdexamfetamine n=1 Participants Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
Change in Clinical Global Impressions Improvement (CGI-I) Score.	0 units on a scale	-2 units on a scale

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lisdexamfetamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tara Lauriat

Steward St. Elizabeth's Medical Center

Phone: 617-789-2404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place