Postpartum DepressionPhase 3NCT01386086
Aripiprazole and Resistant Postpartum Depression
A Phase 3 study testing aripiprazole in people with 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
Currently there are no controlled data on the management of postpartum depression that fails to respond to adequate antidepressant therapy. The investigators recently reported that a large number of patients responded to the addition of atypical neuroleptics after having failed antidepressant trials. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Nov 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Euthyroid outpatients aged 18 to 45 years of age
- A DSM-IV diagnosis of major depressive disorder with episode onset within 3 months of delivery
- A 17-item HAM-D score of 18 or more
- Inadequate response to at least one antidepressant drug - defined as a <50% reduction in severity of depression for a duration of >6 weeks ( > than 8 weeks for fluoxetine), determined by the Massachusetts General Hospital Antidepressant Response Questionnaire. Patients having a score of 18 or more on the 17-item HAM-D will be eligible to participate in the study. The primary efficacy endpoint will be mean change in MADRS score, and the secondary endpoint will be mean change in the HAM-D score
- >For patients on psychotropic drugs (other than antidepressants) prior there will be a washout period of two weeks
- Ability to understand English and provide informed consent
Show all 12Show fewer
- Women who delivered a healthy baby close to term (37-42 weeks)
- Use of adequate contraception > Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal.
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days before the start of the investigational product.
- A subject's male partner of fathering potential must use an adequate method of contraception to avoid conception throughout the study [and for at least 4 weeks after the last dose of study drug] to minimize the risk of pregnancy.
Who cannot join
- Women with onset of major depressive disorder during pregnancy
- Presence of another current Axis I disorder such as bipolar disorder, psychotic disorder or obsessive compulsive disorder or a history of psychosis or a history of post-partum mood disorder with psychotic features
- Presence of psychotic symptoms
- History of alcohol or substance abuse within the 12 months before screening
- Any Axis II diagnosis suggestive of likely non-compliance with study requirement or non-responsiveness to pharmacotherapy.
- Women receiving psychotherapy
Show all 11Show fewer
- Women receiving psychotropic drugs not allowed in the study protocol
- Use of quinolone antibiotics such as ciprofloxacin
- Significant medical illness such as end stage renal disease, uncontrolled narrow angle glaucoma and liver disease
- Women considered at high risk for suicide-those that are actively suicidal or have a score of ≥ 3 on item #3 on the 17-item HAMD; or women who, in the opinion of the Investigator, are deemed to be at risk of causing harm to the baby
- Women who are nursing/breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmentation Therapy of Resistant Postpartum Depression With Aripiprazole
Currently there are no controlled data on the management of postpartum depression that fails to respond to adequate antidepressant therapy. The investigators recently reported that a large number of patients responded to the addition of atypical neuroleptics after having failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective in patients with resistant depression but it has not been studied in patients with resistant postpartum depression. The investigators propose to conduct a 6 week open-label study to assess the effectiveness and tolerability of aripiprazole used adjunctively to antidepressants in patients with resistant postpartum depression.
- Conditions
- Postpartum Depression
- Being tested
- aripiprazole
- Keywords
- Aripiprazole, adjunctive therapy, mood stabilizers, major depressive disorder, postpartum, Augmentation therapy, resistant
- Medical subject headings
- Depression, Postpartum, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
The starting dose of aripiprazole will be 2 mg and the dose adjusted to a maximum of 15 daily
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | aripiprazole used adjunctively to antidepressants in patients with resistant postpartum depression Receives: Drug: aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale
To assess the effectiveness of the addition of aripiprazole in the treatment of resistant postpartum depression as measured by the change in mean scores on the Montgomery Asberg Depression Rating Scale between baseline and the study termination endpoint.
Measured: 6 weeks
Secondary outcomes (1)
Udvalg for Kliniske Undersogelser Scale
To assess the tolerability of aripirazole in women with resistant postpartum depression as assessed by the Udvalg for Kliniske Undersogelser Scale.
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 posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Verinder Sharma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Verinder Sharma, MBBS, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386086
- Sponsor's protocol ID
- CN138-623
- Status last verified
- Mar 2016
- First submitted
- 21 Apr 2011
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation Therapy of Resistant Postpartum Depression With Aripiprazole
- ClinicalTrials.gov ID
- NCT01386086
- Acronym / sponsor ID
- CN138-623
- Conditions
- Postpartum Depression
- Keywords
- Aripiprazole, adjunctive therapy, mood stabilizers, major depressive disorder, postpartum, Augmentation therapy, resistant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Jun 2011 (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.
Currently there are no controlled data on the management of postpartum depression that fails to respond to adequate antidepressant therapy. The investigators recently reported that a large number of patients responded to the addition of atypical neuroleptics after having failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective in patients with resistant depression but it has not been studied in patients with resistant postpartum depression. The investigators propose to conduct a 6 week open-label study to assess the effectiveness and tolerability of aripiprazole used adjunctively to antidepressants in patients with resistant postpartum depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: aripiprazolearipiprazole used adjunctively to antidepressants in patients with resistant postpartum depression |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Euthyroid outpatients aged 18 to 45 years of age
- A DSM-IV diagnosis of major depressive disorder with episode onset within 3 months of delivery
- A 17-item HAM-D score of 18 or more
- Inadequate response to at least one antidepressant drug - defined as a <50% reduction in severity of depression for a duration of >6 weeks ( > than 8 weeks for fluoxetine), determined by the Massachusetts General Hospital Antidepressant Response Questionnaire. Patients having a score of 18 or more on the 17-item HAM-D will be eligible to participate in the study. The primary efficacy endpoint will be mean change in MADRS score, and the secondary endpoint will be mean change in the HAM-D score
- >For patients on psychotropic drugs (other than antidepressants) prior there will be a washout period of two weeks
Key exclusion criteria (11 listed)
- Women with onset of major depressive disorder during pregnancy
- Presence of another current Axis I disorder such as bipolar disorder, psychotic disorder or obsessive compulsive disorder or a history of psychosis or a history of post-partum mood disorder with psychotic features
- Presence of psychotic symptoms
- History of alcohol or substance abuse within the 12 months before screening
- Any Axis II diagnosis suggestive of likely non-compliance with study requirement or non-responsiveness to pharmacotherapy.
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 |
|---|---|---|
| aripiprazoleThe starting dose of aripiprazole will be 2 mg and the dose adjusted to a maximum of 15 daily | Drug | Aripiprazole |
Primary outcome
Montgomery Asberg Depression Rating Scale
Time frame: 6 weeks
To assess the effectiveness of the addition of aripiprazole in the treatment of resistant postpartum depression as measured by the change in mean scores on the Montgomery Asberg Depression Rating Scale between baseline and the study termination endpoint.
1 secondary outcome
Udvalg for Kliniske Undersogelser Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
Related trials for Postpartum Depression
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
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, MBBS principal investigator
Western University, Canada
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 aripiprazole in people with 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 17 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Montgomery Asberg Depression Rating Scale (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 17 Mar 2016.