BipolarPhase 3NCT01131559
Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression
A Phase 3 study testing Lisdexamfetamine in people with Bipolar and 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 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
- 50 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
- Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,
Who cannot join
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
- 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 lisdexamfetamine in the adjunctive treatment of bipolar disorder.
- Conditions
- Bipolar, Depression
- Being tested
- Lisdexamfetamine, Placebo control
- Keywords
- bipolar disorder, manic depression, depression, Bipolar I or II
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisdexamfetamineDrug
Also called Vyvanse
Oral; 20-70mg/day
Placebo controlDrug
Also called Sugar pill, fake pill with no active medication
Oral; 20-70mg/day
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine | Active comparator | Drug Receives: Drug: Lisdexamfetamine |
| Placebo | Placebo comparator | Drug Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS score
The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.
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 posted27 May 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Sponsor halted study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BipolarStudies 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
- 50 participants (estimated)
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
- NCT01131559
- Sponsor's protocol ID
- Adjunctive LDX in BP
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2010
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Lisdexamfetamine in Bipolar Depression
- ClinicalTrials.gov ID
- NCT01131559
- Acronym / sponsor ID
- Adjunctive LDX in BP
- Conditions
- Bipolar, Depression
- Keywords
- bipolar disorder, manic depression, depression, Bipolar I or II
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor halted study.
- Enrolment
- 50 participants (estimated)
- 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
- 27 May 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 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: Placebo controlDrug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,
Key exclusion criteria (2 listed)
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
- 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 |
|---|---|---|
| LisdexamfetamineAlso: VyvanseOral; 20-70mg/day | Drug | Lisdexamfetamine |
| Placebo controlAlso: Sugar pill, fake pill with no active medicationOral; 20-70mg/day | Drug | Placebo |
Primary outcome
Change in MADRS score
Time frame: 30-36 months
The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.
Results and safety
The study was stopped early (reason given: Sponsor halted study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Link to facility where study is conductedLink provided by the sponsor.
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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 and 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 2 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 5 Mar 2014. 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: Sponsor halted study.). 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 MADRS score (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?
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 5 Mar 2014; AzTrials last refreshed its copy on 1 Nov 2026.