Bipolar DepressionPhase 3NCT01093963
Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression
A Phase 3 study testing Lisdexamfetamine in people with Bipolar Depression, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Lisdexamfetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, through the ages of 18 and 55 years, inclusive.
Who cannot join
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
- Subjects who are displaying clinically significant homicidality or suicidality
- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Lisdexamfetamine in Bipolar Depression
The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.
- Conditions
- Bipolar Depression
- Being tested
- Lisdexamfetamine, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisdexamfetamineDrug
oral; 20-70mg/day
PlaceboDrug
oral; 20-70mg/day
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine | Active comparator | Drug Receives: Drug: Lisdexamfetamine |
| Placebo | Placebo comparator | Drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Montgomery-Asberg Depression Rating Scale
Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 30-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Enrollment goals not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Shire, University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093963
- Sponsor's protocol ID
- LDX BP
- Status last verified
- Aug 2015
- First submitted
- 25 Mar 2010
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McElroy SL, Martens BE, Mori N, Blom TJ, Casuto LS, Hawkins JM, Keck PE Jr. Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jan;30(1):6-13. doi: 10.1097/YIC.0000000000000051.
PubMed 25340384
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Lisdexamfetamine in Bipolar Depression
- ClinicalTrials.gov ID
- NCT01093963
- Acronym / sponsor ID
- LDX BP
- Conditions
- Bipolar Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment goals not met
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Shire, University of Cincinnati
- Study start
- Jan 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine | Active comparator | Drug: LisdexamfetamineDrug |
| Placebo | Placebo comparator | Drug: PlaceboDrug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women, through the ages of 18 and 55 years, inclusive.
Key exclusion criteria (3 listed)
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
- Subjects who are displaying clinically significant homicidality or suicidality
- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisdexamfetamineoral; 20-70mg/day | Drug | Lisdexamfetamine |
| Placebooral; 20-70mg/day | Drug | Placebo |
Primary outcome
Change in the Montgomery-Asberg Depression Rating Scale
Time frame: 30-36 months
Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)
Results and safety
The study was stopped early (reason given: Enrollment goals not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Results publication: PubMed 25340384McElroy SL, Martens BE, Mori N, Blom TJ, Casuto LS, Hawkins JM, Keck PE Jr. Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jan;30(1):6-13. doi: 10.1097/YIC.0000000000000051.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lisdexamfetamine in people with Bipolar Depression, run by Lindner Center of HOPE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment goals not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Montgomery-Asberg Depression Rating Scale (time frame: 30-36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.