Bipolar DisorderPhase 3NCT02726659
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression
A Phase 3 study testing Celecoxib in people with Bipolar Disorder and Postpartum Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bipolar Disorder, Postpartum Depression
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 16 Jan 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton
- diagnosis of bipolar postpartum depression - depressed with peripartum onset
- have a 17-item Hamilton Rating Scale for Depression score of >18
- have failed to respond to an adequate trial of the mood stabilizer
- are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)
- are able to communicate (written and oral) in English and capable of giving consent
Who cannot join
- current major depressive episode of more than 6 months duration
- a current comorbid psychiatric disorder
- history of alcohol or substance abuse within the 12 months before screening
- concurrent psychotherapy
- high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)
- current hepatic, renal, or cardiac disease, chronic pain, coagulation disorders, esophageal or gastro duodenal ulceration within the previous 30 days
- known immediate-type hypersensitivity to COX-2 inhibitors, sulfonamides, ibuprofen, or diclofenac
- breastfeeding mothers
Trial locations and contacts
1 site in 1 country.
Canada1 site
Parkwood Institute, Mental Health Care Buildling
London, Ontario, N6C 0A7
About this study
Official title: Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar disorder in the postpartum treatment will receive either a placebo or celecoxib add-on treatment. Patients will be monitored regularly to assess psychiatric symptoms and side effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib in bipolar postpartum depression.
- Conditions
- Bipolar Disorder, Postpartum Depression
- Being tested
- Celecoxib, Placebo
- Medical subject headings
- Bipolar Disorder, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Adjunct celecoxib
PlaceboDrug
Adjunct placebo
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Experimental | Adjunct celecoxib in 6 week treatment Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Adjunct placebo in 6 week treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression by the change in mean scores on the HAM-D between baseline and the 6 weeks endpoint. Response will be a > 50% reduction in HAM-D score and remission will be a < 7 HAM-D score from baseline to week 6.
Measured: 6 weeks
Secondary outcomes (4)
Montgomery Asberg Depression Scale
To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression as measured by the change in the mean scores on the Montgomery Asberg Depression Rating Scale between baseline and the study termination endpoint.
Measured: 6 weeks
Udvalg for Kliniske Undersogelser Scale
To assess the tolerability of celecoxib in women with bipolar postpartum depression as assessed by the Udvalg for Kliniske Undersogelser Scale.
Measured: 6 weeks
Edinburgh Postnatal Depression Scale (EPDS)
To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression as measured by the mean change in scores on the EPDS between baseline and the study termination endpoint.
Measured: 6 weeks
Clinical Global Impression Scale (CGI)
To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression as measured by the change in scores on the CGI between baseline and the study termination endpoint.
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 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Why it stopped: Difficulty recruiting participants because principal investigator noticed that the participants in the population were responding well to low doses of mood stabilizers and therefor would not be recruited into the study.
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Verinder Sharma, MB BS, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726659
- Sponsor's protocol ID
- 107775
- Status last verified
- Nov 2018
- First submitted
- 15 Mar 2016
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02726659
- Acronym / sponsor ID
- 107775
- Conditions
- Bipolar Disorder, Postpartum Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting participants because principal investigator noticed that the participants in the population were responding well to low doses of mood stabilizers and therefor would not be recruited into the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 4 Apr 2016 (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 investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar disorder in the postpartum treatment will receive either a placebo or celecoxib add-on treatment. Patients will be monitored regularly to assess psychiatric symptoms and side effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib in bipolar postpartum depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibAdjunct celecoxib in 6 week treatment |
| Placebo | Placebo comparator | Drug: PlaceboAdjunct placebo in 6 week treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton
- diagnosis of bipolar postpartum depression - depressed with peripartum onset
- have a 17-item Hamilton Rating Scale for Depression score of >18
- have failed to respond to an adequate trial of the mood stabilizer
- are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)
Key exclusion criteria (8 listed)
- current major depressive episode of more than 6 months duration
- a current comorbid psychiatric disorder
- history of alcohol or substance abuse within the 12 months before screening
- concurrent psychotherapy
- high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)
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 |
|---|---|---|
| CelecoxibAlso: CelebrexAdjunct celecoxib | Drug | Celecoxib |
| PlaceboAdjunct placebo | Drug | Placebo |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 6 weeks
To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression by the change in mean scores on the HAM-D between baseline and the 6 weeks endpoint. Response will be a > 50% reduction in HAM-D score and remission will be a < 7 HAM-D score from baseline to week 6.
4 secondary outcomes
Montgomery Asberg Depression Scale
Time frame: 6 weeks
Udvalg for Kliniske Undersogelser Scale
Time frame: 6 weeks
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 6 weeks
Clinical Global Impression Scale (CGI)
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Difficulty recruiting participants because principal investigator noticed that the participants in the population were responding well to low doses of mood stabilizers and therefor would not be recruited into the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: Yes. A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Verinder Sharma, MB BS principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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 Celecoxib in people with Bipolar Disorder and Postpartum Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 6 inclusion and 8 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 20 Jan 2022. 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: Difficulty recruiting participants because principal investigator noticed that the participants in the population were responding well to low doses of mood stabilizers and therefor would not be recruited into the 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?
Hamilton Rating Scale for Depression (HAM-D) (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 20 Jan 2022.