Bipolar DepressionPhase 2NCT01807741
Asenapine for Bipolar Depression
A Phase 2 study testing Asenapine in people with Bipolar Depression, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks. We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Asenapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2017
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Meet criteria for bipolar depression based on the MINI and confirmation of a previous manic or mixed episode
- 18-55 years of age
- Female patients must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence)
- Each patient must understand the nature of the study and must provide written informed consent
- Patients must have a diagnosis of bipolar disorder, type I and currently display an acute depressive episode as determined by M.I.N.I. (Sheehan et al, 1998)
- Patients must have a baseline (day 0) MADRS score ≥26
- Current episode of depression must have persisted for at least one month and no more than six months at study entry
- Subjects should be fluent in English
Who cannot join
- Female patients who are either pregnant or lactating
- Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions
- Any history of current or past diabetes that was treated with pharmacological intervention
- Neurological disorders including epilepsy, stroke, or severe head trauma
- Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, thyroid indices and EKG
- Depression due to a general medical condition or substance-induced depression (DSM-IV)
Show all 17Show fewer
- Mental retardation (IQ <70)
- Meeting criteria for a mixed episode, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- History of hypersensitivity to or intolerance of asenapine
- Prior history of asenapine non-response
- DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months
- Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline MADRS suicide score of >4)
- Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry
- Failure of the current depressive episode to respond to two or more pharmacological interventions
- Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0
- Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV
- Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks.
We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.
Read the detailed description
86 patients with an episode of major depression associated with bipolar disorder, type I will be recruited by two sites for the study over fifteen months. Medication will be administered in a double-blind manner. Patients will receive asenapine (or placebo) beginning on day 0 at 5 mg bid. Dose may be increased to 10 mg bid and adjusted based on clinical response. Patients will be evaluated by a blinded (to treatment status) rater. Patients will be seen and ratings obtained at baseline (day 0) and on days 7, 14, 28, 42, and 56 (or termination from the study). Adverse events will be evaluated as well.
- Conditions
- Bipolar Depression
- Being tested
- Asenapine, Placebo
- Keywords
- Bipolar Disorder, Depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
Also called Saphris
Available in 5 and 10 mg.
PlaceboDrug
Also called sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Asenapine Group | Experimental | Asenapine will be given beginning on day 0 at 5 mg bid. Dose will be increased to 10 mg bid if there is less than 50% decrease in MADRS score by week 2. Dose increases may be held if clinically indicated. Doses may be decreased at any time, if clinically indicated, by increments of 5 mg/day to a minimum of 5 mg qHS. Daily treatment with asenapine will be for 8 weeks. Receives: Drug: Asenapine |
| Placebo Group | Active comparator | Sublingual tablets similar to the asenapine tablets. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Score
The Montgomery-Asberg Depression Rating Scale (MADRS)will be used as a measure of efficacy reflecting change in MADRS total scores from baseline to endpoint over 8 weeks.
Measured: 8 weeks
Secondary outcomes (1)
Change in Depression Response Rate
MADRS Response Rate: Defined by a ≥ 50% decrease from baseline to endpoint in MADRS total score over 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: funding ended due to recruitment delays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Caleb M. Adler, University of Cincinnati
- Investigators
- Caleb M Adler, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807741
- Sponsor's protocol ID
- 2012-4181
- Status last verified
- Jul 2017
- First submitted
- 6 Mar 2013
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asenapine for Bipolar Depression
- ClinicalTrials.gov ID
- NCT01807741
- Acronym / sponsor ID
- 2012-4181
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Disorder, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding ended due to recruitment delays
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- University of Louisville, Merck Sharp & Dohme LLC
- Study start
- Sep 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 8 Mar 2013 (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 purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks.
We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.
Detailed description
86 patients with an episode of major depression associated with bipolar disorder, type I will be recruited by two sites for the study over fifteen months. Medication will be administered in a double-blind manner. Patients will receive asenapine (or placebo) beginning on day 0 at 5 mg bid. Dose may be increased to 10 mg bid and adjusted based on clinical response. Patients will be evaluated by a blinded (to treatment status) rater. Patients will be seen and ratings obtained at baseline (day 0) and on days 7, 14, 28, 42, and 56 (or termination from the study). Adverse events will be evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asenapine Group | Experimental | Drug: AsenapineAsenapine will be given beginning on day 0 at 5 mg bid. Dose will be increased to 10 mg bid if there is less than 50% decrease in MADRS score by week 2. Dose increases may be held if clinically indicated. Doses may be decreased at any time, if clinically indicated, by increments of 5 mg/day to a minimum of 5 mg qHS. Daily treatment with asenapine will be for 8 weeks. |
| Placebo Group | Active comparator | Drug: PlaceboSublingual tablets similar to the asenapine tablets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Meet criteria for bipolar depression based on the MINI and confirmation of a previous manic or mixed episode
- 18-55 years of age
- Female patients must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence)
- Each patient must understand the nature of the study and must provide written informed consent
- Patients must have a diagnosis of bipolar disorder, type I and currently display an acute depressive episode as determined by M.I.N.I. (Sheehan et al, 1998)
Key exclusion criteria (17 listed)
- Female patients who are either pregnant or lactating
- Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions
- Any history of current or past diabetes that was treated with pharmacological intervention
- Neurological disorders including epilepsy, stroke, or severe head trauma
- Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, thyroid indices and EKG
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 |
|---|---|---|
| AsenapineAlso: SaphrisAvailable in 5 and 10 mg. | Drug | Asenapine Group |
| PlaceboAlso: sugar pill | Drug | Placebo Group |
Primary outcome
Change in Depression Score
Time frame: 8 weeks
The Montgomery-Asberg Depression Rating Scale (MADRS)will be used as a measure of efficacy reflecting change in MADRS total scores from baseline to endpoint over 8 weeks.
1 secondary outcome
Change in Depression Response Rate
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: funding ended due to recruitment delays). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
Related trials for Bipolar Depression
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingPhase 2
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Bipolar I Disorder
RecruitingPhase 3
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Bipolar Disorder (BD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
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.
Caleb M Adler, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asenapine in people with Bipolar Depression, run by University of Cincinnati 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 8 inclusion and 17 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 24 Jul 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: funding ended due to recruitment delays). 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 Depression Score (time frame: 8 weeks). 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 24 Jul 2017.