Bipolar I DisorderPhase 3NCT00958633
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
A Phase 3 study testing Escitalopram and Bupropion XL in people with Bipolar I Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Escitalopram and Bupropion XL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to 20 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OPEN-LABEL ACUTE TREATMENT PHASE
- Diagnosed with BD, current episode depressed, with a MADRS score ≥ 20 at both the screening and baseline assessments
- The duration of the current depressive episode is ≥ 2 weeks but ≤ 52 weeks
- Taking or initiating treatment with an anti-manic medication at a therapeutic dose. Anti-manic medications and therapeutic doses are: lithium, serum level 0.6-1.4 mEq/L; divalproex, serum level 350-700 mM; risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; and ziprasidone 80-160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day, are also permitted.
- If taking any other psychoactive medication (other than lorazepam ≤ 4 mg/day or equivalent), is agreeable to tapering and discontinuing it over a period of ≤ 4 weeks
- If female and of childbearing potential, is using an adequate method of contraception.
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- Aged 18-70 years, inclusive
- Fluent in English and capable of providing informed consent
- DOUBLE-BLIND MAINTENANCE TREATMENT PHASE
- Patients meeting all of the following criteria will be eligible to be included in the double-blind study phase:
- Taking escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day, in addition to their anti-manic medication.
- Has adequately tolerated the combination of antidepressant plus mood stabilizer, and is currently in remission for ≥ 2 weeks and ≤ 8 weeks
- If female and of childbearing potential, is using an adequate method of contraception
Who cannot join
- OPEN-LABEL ACUTE TREATMENT PHASE
- Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months
- Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a Young Mania Rating Scale (YMRS) score ≥ 8 at the screening or baseline visits
- Has previously been refractory to treatment with both escitalopram and bupropion XL, or has been unable to tolerate both medications due to intolerable side effects or an allergic reaction
- Is taking monoamine oxidase inhibitors, such as phenelzine or tranylcypromine
- Escitalopram is contraindicated in patients taking pimozide or ziprasidone. Patients on pimozide or ziprasidone can participate in the study and will be prescribed bupropion XL
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- Bupropion XL is contraindicated in patients taking other preparations containing bupropion, in patients with active eating disorders, including anorexia nervosa and bulimia nervosa; and in patients with seizure disorders. Patients with any of these can still participate in the study and will be prescribed Escitalopram
- Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study
- Is at high risk for suicide, as defined by a score of ≥ 4 on the suicide item of the MADRS, or in the opinion of the investigator
- Has an unstable medical illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator
- Has significant abnormalities on an electrocardiogram
- Is pregnant or lactating
- DOUBLE-BLIND MAINTENANCE TREATMENT PHASE
- Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months
- Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a YMRS score ≥ 8 at the screening or baseline visits
- Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study
- Is at high risk for suicide, as defined by a score of ≥ 4 on the suicide item of the MADRS, or in the opinion of the investigator
- Has an unstable medical illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator.
- Has significant abnormalities on an electrocardiogram
- Is pregnant or lactating
- Has experienced an episode of mania, hypomania, or a mixed episode during antidepressant treatment of the acute depression, defined as a YMRS score of ≥ 16 at any open-label study visit, or in the opinion of the study psychiatrist
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2A1
About this study
Official title: Mood Stabilizer Plus Antidepressant Versus Mood Stabilizer Plus Placebo in the Maintenance Treatment of Bipolar Disorder
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients. However, no placebo-controlled trials have assessed the efficacy or safety of modern antidepressants in combination with mood stabilizers in the maintenance treatment of BD. The investigators propose a multicentre, randomized, double-blind clinical trial comparing mood stabilizer plus antidepressant (escitalopram or bupropion XL) to mood stabilizer plus placebo in the maintenance treatment of BD.
The investigators hypothesize that in clinically representative patients with bipolar disorder, who respond to acute treatment with a newer antidepressant medication in conjunction with a mood stabilizing medication, continuing the antidepressant for 12 months will reduce the risk of relapse into any mood episode, including depression, mania, and hypomania, compared to stopping the antidepressant after 8 weeks.
Read the detailed description
Study Design:
The investigators propose a multicentre, randomized, double-blind, placebo-controlled trial in patients with BD who are currently experiencing a depressive episode. The trial will consist of two phases: an open-label acute treatment phase, and a double-blind maintenance treatment phase.
OPEN-LABEL ACUTE TREATMENT PHASE
Experimental Design Patients with BD depression who are receiving treatment with antimanic medication(s), defined as: 1) a mood stabilizer (lithium or divalproex ), 2) a second-generation antipsychotic (SGA) (risperidone, olanzapine, quetiapine, aripiprazole, or ziprasidone), or 3) combination anti-manic therapy (two mood stabilizers; or a mood stabilizer plus an SGA (the SGA asenapine will also be permitted if prescribed with a mood stabilizer); or a mood stabilizer or SGA plus lamotrigine), will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.
DOUBLE-BLIND MAINTENANCE TREATMENT PHASE
Patients who are in remission from their index depression for ≥ 2 weeks and ≤ 8 weeks are eligible to take part in the double-blind maintenance phase. There are two routes to enter the double-blind phase:
- following completion of the open-label phase, or
- following a period of clinical treatment, not exceeding 16 weeks, with the same medications used in the open-label phase. Patients who respond to clinical treatment with carbamazepine plus an antidepressant may also enter the double-blind phase.
Experimental Design
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
- Patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines..
- Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
- Conditions
- Bipolar I Disorder
- Being tested
- Escitalopram, Bupropion XL
- Keywords
- Bipolar I disorder, Depression, Antidepressant
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro/Cipralex
Escitalopram will be prescribed in the dose range 10-30 mg daily.
In patients randomized to the "8-week group:
- escitalopram will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of escitalopram (or matching placebo) may be decreased in 10 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 10-30 mg daily at all time points.
Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Bupropion XLDrug
Also called Wellbutrin
Bupropion XL will be prescribed in the dosage range 150-450 mg daily.
In patients randomized to the "8-week group:
- bupropion XL will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of bupropion XL (or matching placebo) may be decreased in 150 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 150-450 mg daily at all time points.
Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
| Study group | Role | What they receive |
|---|---|---|
| 8 week arm | Active comparator | During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg Receives: Drug: Escitalopram; Drug: Bupropion XL |
| 52 week arm | Active comparator | During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg Receives: Drug: Escitalopram; Drug: Bupropion XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double-Blind Phase: Number of Participants With an Occurrence of Any Mood Episode (Manic, Hypo-manic, Depressive) During the 52 Week Study Period.
The primary outcome, assessed in a time-to-event analysis, was any mood episode, defined as any of the following: a Young Mania Rating Scale (YMRS) score of at least 16 (mild mania), a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 (moderate depression), a Clinical Global Impressions Scale, Bipolar Version, Severity (CGI-S-BD) score of at least 4 for mania or depression (moderately ill), hospitalization for mood symptoms, necessity of additional pharmacotherapy for emerging mood symptoms, a MADRS suicide item score of at least 4 (scores range from 0 to 6, with higher scores indicating greater suicide risk), or a suicide attempt or suicide death.
Young Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes.
Clinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.
Measured: 52 weeks
Secondary outcomes (1)
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Time to a depressive episode, a manic or hypomanic episode, discontinuation from the trial for any clinical reason (e.g., occurrence of a mood event, withdrawal of informed consent, or adverse event), any mood episode or subsyndromal symptoms, time spent in these episodes, and scores on the CGI-BD, YMRS, and MADRS clinical rating scales.
Young Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes.
Clinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startNov 2010
- Primary completion31 Mar 2020
- Study completion20 May 2020
Why it stopped: Recruitment was stopped before the planned sample size was reached owing to the Covid-19 pandemic and expiration of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), GlaxoSmithKline, Lundbeck Canada Inc., Lupin Limited
- Responsible party
- Principal investigator, Lakshmi N Yatham, University of British Columbia
- Investigators
- Lakshmi Yatham, Dr., Principal investigator, University of British ColumbiaB. Frey, Dr., Study director, St. Joseph's Healthcare, Hamilton, Ont.S. Beaulieu, Dr., Study director, Douglas Mental Health University Institute, Montreal, QuebecA. Daigneault, Dr., Study director, Douglas Mental Health University Institute, Montreal, QuebecA. Ravindran, Dr., Study director, Centre for Addictions and Mental Health, Toronto, Ont.A. Schaffer, Dr., Study director, Sunnybrook Health Sciences Centre, Toronto, Ont.R. Milev, Dr., Study director, Queen's University, Kingston, OntarioP. Cervantes, Dr., Study director, McGill University Health Centre, Montreal, Que
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958633
- Sponsor's protocol ID
- H09-01017
- Status last verified
- May 2025
- First submitted
- 11 Aug 2009
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yatham LN, Arumugham SS, Kesavan M, Ramachandran K, Murthy NS, Saraf G, Ouyang Y, Bond DJ, Schaffer A, Ravindran A, Ravindran N, Frey BN, Daigneault A, Beaulieu S, Lam RW, Kondapuram N, Reddy MS, Bhandary RP, Ashok MV, Ha K, Ahn YM, Milev R, Wong H, Reddy YCJ; BEAM-BD Trial Group. Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression. N Engl J Med. 2023 Aug 3;389(5):430-440. doi: 10.1056/NEJMoa2300184.
PubMed 37530824
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Stabilizer Plus Antidepressant Versus Mood Stabilizer Plus Placebo in the Maintenance Treatment of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00958633
- Acronym / sponsor ID
- H09-01017
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I disorder, Depression, Antidepressant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped before the planned sample size was reached owing to the Covid-19 pandemic and expiration of funding.
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), GlaxoSmithKline, Lundbeck Canada Inc., Lupin Limited
- Study start
- Nov 2010
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients. However, no placebo-controlled trials have assessed the efficacy or safety of modern antidepressants in combination with mood stabilizers in the maintenance treatment of BD. The investigators propose a multicentre, randomized, double-blind clinical trial comparing mood stabilizer plus antidepressant (escitalopram or bupropion XL) to mood stabilizer plus placebo in the maintenance treatment of BD.
The investigators hypothesize that in clinically representative patients with bipolar disorder, who respond to acute treatment with a newer antidepressant medication in conjunction with a mood stabilizing medication, continuing the antidepressant for 12 months will reduce the risk of relapse into any mood episode, including depression, mania, and hypomania, compared to stopping the antidepressant after 8 weeks.
Detailed description
Study Design:
The investigators propose a multicentre, randomized, double-blind, placebo-controlled trial in patients with BD who are currently experiencing a depressive episode. The trial will consist of two phases: an open-label acute treatment phase, and a double-blind maintenance treatment phase.
OPEN-LABEL ACUTE TREATMENT PHASE
Experimental Design Patients with BD depression who are receiving treatment with antimanic medication(s), defined as: 1) a mood stabilizer (lithium or divalproex ), 2) a second-generation antipsychotic (SGA) (risperidone, olanzapine, quetiapine, aripiprazole, or ziprasidone), or 3) combination anti-manic therapy (two mood stabilizers; or a mood stabilizer plus an SGA (the SGA asenapine will also be permitted if prescribed with a mood stabilizer); or a mood stabilizer or SGA plus lamotrigine), will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.
DOUBLE-BLIND MAINTENANCE TREATMENT PHASE
Patients who are in remission from their index depression for ≥ 2 weeks and ≤ 8 weeks are eligible to take part in the double-blind maintenance phase. There are two routes to enter the double-blind phase:
- following completion of the open-label phase, or
- following a period of clinical treatment, not exceeding 16 weeks, with the same medications used in the open-label phase. Patients who respond to clinical treatment with carbamazepine plus an antidepressant may also enter the double-blind phase.
Experimental Design
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
- Patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines..
- Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 week arm | Active comparator | Drug: Escitalopram, Drug: Bupropion XLDuring the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks: Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks. Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg |
| 52 week arm | Active comparator | Drug: Escitalopram, Drug: Bupropion XLDuring the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks: Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study. Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- OPEN-LABEL ACUTE TREATMENT PHASE
- Diagnosed with BD, current episode depressed, with a MADRS score ≥ 20 at both the screening and baseline assessments
- The duration of the current depressive episode is ≥ 2 weeks but ≤ 52 weeks
- Taking or initiating treatment with an anti-manic medication at a therapeutic dose. Anti-manic medications and therapeutic doses are: lithium, serum level 0.6-1.4 mEq/L; divalproex, serum level 350-700 mM; risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; and ziprasidone 80-160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day, are also permitted.
- If taking any other psychoactive medication (other than lorazepam ≤ 4 mg/day or equivalent), is agreeable to tapering and discontinuing it over a period of ≤ 4 weeks
Key exclusion criteria (21 listed)
- OPEN-LABEL ACUTE TREATMENT PHASE
- Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months
- Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a Young Mania Rating Scale (YMRS) score ≥ 8 at the screening or baseline visits
- Has previously been refractory to treatment with both escitalopram and bupropion XL, or has been unable to tolerate both medications due to intolerable side effects or an allergic reaction
- Is taking monoamine oxidase inhibitors, such as phenelzine or tranylcypromine
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 |
|---|---|---|
| EscitalopramAlso: Lexapro/CipralexEscitalopram will be prescribed in the dose range 10-30 mg daily. In patients randomized to the "8-week group: * escitalopram will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of escitalopram (or matching placebo) may be decreased in 10 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 10-30 mg daily at all time points. Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study. | Drug | 52 week arm, 8 week arm |
| Bupropion XLAlso: WellbutrinBupropion XL will be prescribed in the dosage range 150-450 mg daily. In patients randomized to the "8-week group: * bupropion XL will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of bupropion XL (or matching placebo) may be decreased in 150 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 150-450 mg daily at all time points. Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study. | Drug | 52 week arm, 8 week arm |
Primary outcome
Double-Blind Phase: Number of Participants With an Occurrence of Any Mood Episode (Manic, Hypo-manic, Depressive) During the 52 Week Study Period.
Time frame: 52 weeks
The primary outcome, assessed in a time-to-event analysis, was any mood episode, defined as any of the following: a Young Mania Rating Scale (YMRS) score of at least 16 (mild mania), a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 (moderate depression), a Clinical Global Impressions Scale, Bipolar Version, Severity (CGI-S-BD) score of at least 4 for mania or depression (moderately ill), hospitalization for mood symptoms, necessity of additional pharmacotherapy for emerging mood symptoms, a MADRS suicide item score of at least 4 (scores range from 0 to 6, with higher scores indicating greater suicide risk), or a suicide attempt or suicide death. Young Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes. Clinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.
1 secondary outcome
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37530824Yatham LN, Arumugham SS, Kesavan M, Ramachandran K, Murthy NS, Saraf G, Ouyang Y, Bond DJ, Schaffer A, Ravindran A, Ravindran N, Frey BN, Daigneault A, Beaulieu S, Lam RW, Kondapuram N, Reddy MS, Bhandary RP, Ashok MV, Ha K, Ahn YM, Milev R, Wong H, Reddy YCJ; BEAM-BD Trial Group. Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression. N Engl J Med. 2023 Aug 3;389(5):430-440. doi: 10.1056/NEJMoa2300184.
- Individual participant dataSharing planned: No
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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.
Lakshmi Yatham, Dr. principal investigator
University of British Columbia
B. Frey, Dr. study director
St. Joseph's Healthcare, Hamilton, Ont.
S. Beaulieu, Dr. study director
Douglas Mental Health University Institute, Montreal, Quebec
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 Escitalopram and Bupropion XL in people with Bipolar I Disorder, run by University of British Columbia at 1 site in Canada.
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 13 inclusion and 21 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 15 May 2025. 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 Canada. 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 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?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Double-Blind Phase: Number of Participants With an Occurrence of Any Mood Episode (Manic, Hypo-manic, Depressive) During the 52 Week Study Period. (time frame: 52 weeks). 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 NCT00958633, 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 15 May 2025.