Bipolar DisorderPhase 3NCT01520350
Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study
A Phase 3 study testing Low dose Adjunctive Aripiprazole in people with Bipolar Disorder and Depressive Episode, run by Serge Beaulieu at 1 site in Canada.
Trial summary
Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the 5-HT2a receptor, and an agonist of the 5-HT1a receptor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Depressive Episode
- What is being tested?
- Low dose Adjunctive Aripiprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jun 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : 18-65
- Male or female
- Bipolar Disorder type I
- Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit)
- If female and of childbearing potential, is using an adequate method of contraception.
- Is treated with a mood stabilizer (lithium and/or valproate)
- Patient is able to give his consent
Who cannot join
- Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator
- Hypo(mania) episode with YMRS ≥ 8
- Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
- Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants
- Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics
- Is pregnant or lactating or absence of contraceptive treatment
Show all 21Show fewer
- Drug abuse or dependence as per DSM-IV (MINI)
- Unstable medical condition
- Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension
- Deficit in vitamin B12 or folate
- Alcohol or drug abuse
- Rapid cycling (more than 4 mood episodes per year)
- Active or history of difficulty to swallow
- Seizures not currently controlled with medications
- Orthostatic hypotension
- A history of clinically significant cardiovascular disorders and cardiac arrhythmias
- A low white blood cell count
- Known eye disease
- Involuntary, irregular muscle movements, especially in the face
- Known hypersensitivity to aripiprazole and any components of its formulation
- Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the 5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties should enable this molecule to provide antidepressant potentiating capabilities based on what has been observed with other compounds sharing similar pharmacological profiles.
Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the treatment of unipolar depression. However, two randomized controlled trials of aripiprazole in the treatment of bipolar depression were negative. This surprising result may stem from the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3 mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit dopaminergic activity in key brain areas involved in the modulation of rewards, motivation and concentration. Bipolar depression is indeed heavily loaded with general symptoms of psychomotor retardation including poor concentration, low energy level, hypersomnolence, and hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving dopaminergic function are used frequently to resolve residual symptoms of bipolar depression.
It is expected that aripiprazole used at a more adequate lower dose than in previous studies, should be efficacious in the treatment of bipolar type I depression.
- Conditions
- Bipolar Disorder, Depressive Episode
- Being tested
- Low dose Adjunctive Aripiprazole, 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.
Low dose Adjunctive AripiprazoleDrug
Also called Abilify
low-dose 2-5mg/d for 8 weeks
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mood stabilizer + Aripiprazole | Experimental | Not described Receives: Drug: Low dose Adjunctive Aripiprazole |
| Mood stabilizer + placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The primary outcome measure will be the response rate as defined by a differential reduction of 5 points on the Montgomery Asberg rating Scale (MADRS) between the active treatment group and the placebo group at 8 weeks of treatment.
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 posted27 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serge Beaulieu
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Serge Beaulieu, Douglas Mental Health University Institute
- Investigators
- Serge Beaulieu, MD, PhD, Principal investigator, Douglas Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520350
- Sponsor's protocol ID
- ARI_1109
- Status last verified
- Jul 2014
- First submitted
- 25 Jan 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01520350
- Acronym / sponsor ID
- ARI_1109
- Conditions
- Bipolar Disorder, Depressive Episode
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Serge BeaulieuUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2012 (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.
Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the 5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties should enable this molecule to provide antidepressant potentiating capabilities based on what has been observed with other compounds sharing similar pharmacological profiles.
Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the treatment of unipolar depression. However, two randomized controlled trials of aripiprazole in the treatment of bipolar depression were negative. This surprising result may stem from the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3 mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit dopaminergic activity in key brain areas involved in the modulation of rewards, motivation and concentration. Bipolar depression is indeed heavily loaded with general symptoms of psychomotor retardation including poor concentration, low energy level, hypersomnolence, and hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving dopaminergic function are used frequently to resolve residual symptoms of bipolar depression.
It is expected that aripiprazole used at a more adequate lower dose than in previous studies, should be efficacious in the treatment of bipolar type I depression.
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 |
|---|---|---|
| Mood stabilizer + Aripiprazole | Experimental | Drug: Low dose Adjunctive Aripiprazole |
| Mood stabilizer + placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age : 18-65
- Male or female
- Bipolar Disorder type I
- Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit)
- If female and of childbearing potential, is using an adequate method of contraception.
Key exclusion criteria (21 listed)
- Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator
- Hypo(mania) episode with YMRS ≥ 8
- Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
- Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants
- Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics
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 |
|---|---|---|
| Low dose Adjunctive AripiprazoleAlso: Abilifylow-dose 2-5mg/d for 8 weeks | Drug | Mood stabilizer + Aripiprazole |
| placeboPlacebo | Drug | Mood stabilizer + placebo |
Primary outcome
Response rate
Time frame: 8 weeks
The primary outcome measure will be the response rate as defined by a differential reduction of 5 points on the Montgomery Asberg rating Scale (MADRS) between the active treatment group and the placebo group at 8 weeks of treatment.
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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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.
Serge Beaulieu, MD, PhD principal investigator
Douglas Institute
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 Low dose Adjunctive Aripiprazole in people with Bipolar Disorder and Depressive Episode, run by Serge Beaulieu 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 7 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 29 Jul 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 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. 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: recruitment issues). 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?
Response rate (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 29 Jul 2014.