TerminatedNCT01051440Updated Jan 30, 2013Results posted

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

A Phase 4 interventional study of Lisdexamfetamine and Placebo in Bipolar Depression, sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc.. Terminated at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-01-30.

Sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc. · Phase 4, Interventional, and Treatment

Why this study was terminated

Slow enrollment

Phase: Phase 4
Study type: Interventional
Enrollment: 2
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: All

Study summary

There have been reports that stimulants may be effective for bipolar depression without triggering mania. This study will examine whether lisdexamfetamine can improve depressive symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the study drug or placebo in addition to a mood stabilizer. The study includes functional magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the medication alters the response to affective stimuli or glutamate, glutamine, or gamma aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine whether the study drug improves memory and attention in this population. The primary hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary hypothesis is that it will result in an increased response to affective stimuli and altered neurotransmitter levels in the anterior cingulate cortex.

Conditions studied

Bipolar Depression

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Keywords

lisdexamfetamine
vyvanse
bipolar disorder
depression
stimulant
magnetic resonance spectroscopy
functional magnetic resonance imaging
neuropsychological testing

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 2 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc. is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Aged 21 to 50 years.
Diagnosed with Bipolar Disorder I or II disorder.
Currently in the depressive phase of the illness.
Montgomery Asberg Depression Rating Scale (MADRS) score greater than 15.
Medication regimen (Lamotrigine, Valproate, Lithium, either alone or in combination with atypical antipsychotics, or typical antipsychotics) at stable doses for at least one month.
Has an established residence and phone.
Capable of providing informed consent.

Exclusion criteria

Exclusion Criteria:

Met Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) criteria for rapid cycling within the 6 months prior to enrolling in the study.
Meets DSM-IV-TR criteria for Schizophrenia, Schizoaffective disorder, Post-Traumatic Stress disorder, Obsessive-Compulsive disorder, or Eating disorder. Co-morbid anxiety disorders are not a reason for exclusion.
History of psychotic symptoms at any point during the subject's illness.
Met DSM-IV-TR criteria for alcohol or substance (except for nicotine) dependence or abuse within the past 6 months.
Lifetime history of amphetamine abuse or dependence.
Subject has a lifetime history of stimulant-induced mania
History of seizures, including febrile seizures in childhood.
Young Mania Rating Scale (YMRS) greater than 8.
History of significant coronary artery disease, angina, untreated or inadequately treated thyroid disease (less than 1 month chemically euthyroid), type I diabetes, autoimmune disease, glaucoma, hypertension, seizures, or other medical condition(s) which in the opinion of the principal investigator is likely to significantly impact the subject's mood or potential response to the study medication.
Electrocardiogram (ECG) with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation; uncontrolled hypertension (>160/100) or tachycardia (heart rate >110).
Female subjects who are peri or post-menopausal.
Subjects taking Ritalin or other stimulants, theophylline, steroids, atomoxetine, cholinesterase inhibitors, memantine, modafinil, warfarin, anticonvulsants, clonidine, theophylline, monoamine oxidase inhibitors, and pseudoephedrine, or other medications that are likely to significantly interact (either pharmacokinetically or pharmacodynamically) with the subject's mood or Lisdexamfetamine.
Subject regularly (more than 4 days per week) ingests more than four caffeine containing drinks per day.
Pregnancy.
In women of childbearing potential, an unwillingness to avoid pregnancy for the duration of the study.
Active suicidal ideation.
History of homicidal ideation.
Allergy or other clinical condition which prohibits the use of all of the approved mood stabilizers or Lisdexamfetamine.
Metal in the body (e.g. history of working as a sheet metal worker) or pacemaker which is a contra-indication to magnetic resonance imaging (MRI).
Significant claustrophobia.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 2 participants (actual)

Study arms

Placebo comparator
Placebo
Subjects will receive placebo for lisdexamfetamine.
Drug: Placebo
Active comparator
Lisdexamfetamine
Subjects will start with 20 mg per day of lisdexamfetamine and may increase to a maximum of 40 mg.
Drug: Lisdexamfetamine

Interventions

DrugLisdexamfetamine
Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments.
Also known as: Vyvanse
DrugPlacebo
Subjects will receive placebo matched to lisdexamfetamine.

What researchers measure

Primary outcomes

Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.
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.
Time frame: baseline and 8 weeks

Secondary outcomes

Change in Clinical Global Impressions Severity (CGI-S) Score.
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.
Time frame: baseline and week 8
Change in Clinical Global Impressions Improvement (CGI-I) Score.
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.
Time frame: week 1 and week 9

Results

Posted Jan 30, 2013

Limitations and caveats

The study was terminated before completion due to low enrollment. One subject was randomized to lisdexamfetamine and one was randomized to placebo. Therefore, it was not possible to obtain complete data.

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.

Participant flow — Overall Study
Milestone	Placebo	Lisdexamfetamine
Started	1	1
Completed	1	1
Not completed	0	0

Outcome measures

PrimaryChange in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.

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.

Time frame:: baseline and 8 weeks
Reported as:: Number · units on a scale

Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.
units on a scale	Placebo	Lisdexamfetamine
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.	4 ± 0	-22 ± 0

SecondaryChange in Clinical Global Impressions Severity (CGI-S) Score.

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.

Time frame:: baseline and week 8
Reported as:: Number · units on a scale

Change in Clinical Global Impressions Severity (CGI-S) Score.
units on a scale	Placebo	Lisdexamfetamine
Change in Clinical Global Impressions Severity (CGI-S) Score.	1	-2

SecondaryChange in Clinical Global Impressions Improvement (CGI-I) Score.

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.

Time frame:: week 1 and week 9
Reported as:: Number · units on a scale

Change in Clinical Global Impressions Improvement (CGI-I) Score.
units on a scale	Placebo	Lisdexamfetamine
Change in Clinical Global Impressions Improvement (CGI-I) Score.	0	-2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/1 (0%)	0/1 (0%)
Lisdexamfetamine	—	0/1 (0%)	0/1 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Placebo	Lisdexamfetamine	Total
<=18 years	0	0	0
Between 18 and 65 years	1	1	2
>=65 years	0	0	0

Age Continuous
Age Continuous(years)	Placebo	Lisdexamfetamine	Total
Mean	38 ± 0	30 ± 0	34 ± 5.7

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Lisdexamfetamine	Total
Female	0	0	0
Male	1	1	2

Region of Enrollment
Region of Enrollment(participants)	Placebo	Lisdexamfetamine	Total
United States	1	1	2

Study locations

1 site

Steward St. Elizabeth's Medical Center
Boston, Massachusetts 02135, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01051440
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborators: Shire
Responsible party: Michael Henry, MD (Principal Investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.) — Principal investigator
First posted: Jan 18, 2010
Start date: Feb 2010
Primary completion: Jun 2011
Completion: Jun 2011
Results posted: Jan 30, 2013
Last update: Jan 30, 2013

Study contacts

Michael E Henry, MD

principal investigator · Steward St. Elizabeth's Medical Center of Boston, Inc.

View the source record on ClinicalTrials.gov ↗

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