Bipolar DepressionPhase 1NCT00272025
Treatment Resistant Bipolar Depression
A Phase 1 study testing Escitalopram in people with Bipolar Depression, run by Queen's University at 1 site in Canada.
Trial summary
To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Jan 2010
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Diagnosis of Bipolar Disorder and currently be in depressive state, and not responded to mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.
Who cannot join
- Pregnant or breastfeeding
- History of seizure disorder or other unstable medical condition
- Received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
- Experienced hallucinations or delusions
Trial locations and contacts
1 site in 1 country.
Canada1 site
Providence Care, Mental Health Services
Kingston, Ontario, K7L 4X3
About this study
Official title: Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression
To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients.
- Conditions
- Bipolar Depression
- Being tested
- Escitalopram, placebo
- Keywords
- Bipolar Depression, Escitalopram, Mood Stabilizer, Atypical Antipsychotic
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex
10mg to 20mg tablet daily for 6 weeks
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | There is a 50% chance of being randomized to Escitalopram in addition to current atypical antipsychotic (minimum dose risperidone 3mg, olanzapine 10mg or seroquel 400mg) or mood stabilizer (lithium, epival or lamotrigine) Receives: Drug: Escitalopram |
| 2 | Placebo comparator | to be filled in Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication
Measured: 6 weeks
Secondary outcomes (1)
To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Lundbeck withdrew committment - expiring patents and prolonged inactivity
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen V. Milev, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272025
- Sponsor's protocol ID
- PSIY-207-05
- Status last verified
- Dec 2015
- First submitted
- 3 Jan 2006
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression
- ClinicalTrials.gov ID
- NCT00272025
- Acronym / sponsor ID
- PSIY-207-05
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression, Escitalopram, Mood Stabilizer, Atypical Antipsychotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lundbeck withdrew committment - expiring patents and prolonged inactivity
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Jan 2006 (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.
To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EscitalopramThere is a 50% chance of being randomized to Escitalopram in addition to current atypical antipsychotic (minimum dose risperidone 3mg, olanzapine 10mg or seroquel 400mg) or mood stabilizer (lithium, epival or lamotrigine) |
| 2 | Placebo comparator | Drug: placeboto be filled in |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Diagnosis of Bipolar Disorder and currently be in depressive state, and not responded to mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- History of seizure disorder or other unstable medical condition
- Received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
- Experienced hallucinations or delusions
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: Cipralex10mg to 20mg tablet daily for 6 weeks | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication
Time frame: 6 weeks
1 secondary outcome
To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Lundbeck withdrew committment - expiring patents and prolonged inactivity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
Roumen V. Milev, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Escitalopram in people with Bipolar Depression, run by Queen's University 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 2 inclusion and 4 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 16 Dec 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Lundbeck withdrew committment - expiring patents and prolonged inactivity). 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?
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication (time frame: 6 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 16 Dec 2015.