DepressionPhase 3NCT01527786
Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
A Phase 3 study testing Desvenlafaxine in people with Depression, run by BC Women's Hospital & Health Centre at 1 site in Canada.
Trial summary
Postpartum depressed women suffer from functional impairment in their mood, thoughts, cognition and physical well being leading to poor motivation, bonding difficulties, decreased productivity, conflict and neglect. Moderate/ severe depression responds best to a combination of antidepressants and counseling. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Desvenlafaxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Feb 2014
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be able to read and write English.
- Written informed consent before initiation of any study related procedures.
- Diagnosis of Major Depressive Disorder (MDD) with onset of depressive symptoms within 12 months of delivery.
- Diagnosis of additional comorbid panic, generalized anxiety or obsessive compulsive disorder, if they occur in addition to MDD.
- Patients will be required to have a score of (greater than or equal than) 25 on the Montgomery-Asberg Depression Rating Scale (MADRS) at enrolment (moderate to severe depression).
- Patients need to be referred by their usual treating primary care physician.
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- Those referrals must meet the clinic criteria for accepting referrals so that all potential participants are eligible to receive treatment in the clinic as per usual clinical practice.
- Patient does not wish to pursue CBT elsewhere.
- The patient is using an appropriate method of contraception, which may include abstinence, in order to avoid pregnancy during the study.
- The patient is not currently breastfeeding.
Who cannot join
- The patient is currently breastfeeding or pregnant.
- The patient has a significant risk of suicide according to investigator's opinion or presents a score ³5 on item 10 (suicidal thoughts) of the MADRS.
- The patient meets DSM-IV-TR criteria for:
- current Post-traumatic Stress Disorder,
- past or current manic or hypomanic episode,
- past or current psychotic symptoms or disorder,
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- current drug or alcohol abuse or dependence,
- current eating disorder (anorexia or bulimia).
- The patient uses the following disallowed recent or concomitant medication within the specified time periods:
- any antidepressant or any drug used for augmentation of antidepressant action within the last 1 week and 3 weeks for fluoxetine (longer half life) prior to baseline. Subject's mood will be monitored.
- any hypnotics within the last week prior to baseline
- oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline.
- serotonergic medicinal products (for example, triptans, tryptophan, tramadol) within the last week prior to baseline.
- Psychoactive herbal remedies (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba) within the last 2 weeks prior to baseline.
- any other drug with potential psychotropic effects within the last 2 weeks prior to baseline.
- any anticonvulsant drug within the last 2 weeks prior to baseline.
- any investigational product within 3 months prior to baseline.
- The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy elsewhere, or plans to initiate such therapy during the study outside of the clinic.
- The current depressive symptoms of the patient are considered by the investigator to have been resistant to two well-conducted antidepressant treatments of at least 6 weeks duration.
- The patient has a serious illness or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient's participation in the study, the patient may be included).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
Postpartum depressed women suffer from functional impairment in their mood, thoughts, cognition and physical well being leading to poor motivation, bonding difficulties, decreased productivity, conflict and neglect. Moderate/ severe depression responds best to a combination of antidepressants and counseling. This study will estimate the proportion of women who return to functionality after treatment with Desvenlafaxine and examine the differential impact of change in depression and anxiety symptoms on functionality over twelve weeks. Depression and anxiety symptoms will be monitored through six mood questionnaires; functional recovery will be monitored through a simple self-report questionnaire at each visit.
Read the detailed description
Women will be recruited through a tertiary level care program and advertisements in BC Children's \& Women's Hospital as well as St.Paul's Hospital, Vancouver, B.C., Canada. If deemed eligible for the study (meeting a diagnosis of postpartum depression with or without comorbid anxiety disorder) and the potential participant agrees to participate, consent will be signed. The participant will return on a bi-weekly basis for study visits, where mood and anxiety will be monitored, in addition to blood pressure and weight. Starting dose of Desvenlafaxine is 50mg, and this can be titrated to 100mg/per day if needed. Questionnaires will assess depression symptoms, anxiety symptoms, quality of life, panic disorder, obsessive-compulsive disorder and generalized anxiety disorder.
- Conditions
- Depression
- Being tested
- Desvenlafaxine
- Keywords
- Major Depressive Disorder, Postpartum Onset
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
50mg-100mg everyday for 12 weeks over 7 study visits
| Study group | Role | What they receive |
|---|---|---|
| SNRI treatment | Experimental | Participants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI). Receives: Drug: Desvenlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS), which measures global functional impairment, as well as the individual score on each subscale (work/school; social life; family life/home responsibilities). To provide estimates for further studies, the mean change in score will be estimated with 95% confidence limits as a measure of variability. In addition, the proportion of subjects showing a change of more than clinically important change of more than 5 points will be estimated.
Measured: Baseline
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS), which measures global functional impairment, as well as the individual score on each subscale (work/school; social life; family life/home responsibilities). To provide estimates for further studies, the mean change in score will be estimated with 95% confidence limits as a measure of variability. In addition, the proportion of subjects showing a change of more than clinically important change of more than 5 points will be estimated.
Measured: 12 weeks
Secondary outcomes (3)
Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale- Anxiety (HAM-A), the Yale-Brown Obsessive Compulsive Scale (YBOCS), the Panic Disorder Severity Scale (PDSS), and the Penn Sate Worry Questionnaire (PSWQ).
Secondary efficacy assessment will be comprised of several measures. The secondary endpoint will be change from baseline on the total scores of these measures after 6 and 12-weeks of treatment. Resulting scores from these scales will be used to provide estimates and will be tabulated.
Measured: Baseline
Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale- Anxiety (HAM-A), the Yale-Brown Obsessive Compulsive Scale (YBOCS), the Panic Disorder Severity Scale (PDSS), and the Penn Sate Worry Questionnaire (PSWQ).
Secondary efficacy assessment will be comprised of several measures. The secondary endpoint will be change from baseline on the total scores of these measures after 6 and 12-weeks of treatment. Resulting scores from these scales will be used to provide estimates and will be tabulated.
Measured: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale- Anxiety (HAM-A), the Yale-Brown Obsessive Compulsive Scale (YBOCS), the Panic Disorder Severity Scale (PDSS), and the Penn Sate Worry Questionnaire (PSWQ).
Secondary efficacy assessment will be comprised of several measures. The secondary endpoint will be change from baseline on the total scores of these measures after 6 and 12-weeks of treatment. Resulting scores from these scales will be used to provide estimates and will be tabulated.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startNov 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- BC Women's Hospital & Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shaila Misri, BC Women's Hospital & Health Centre
- Investigators
- Shaila Misri, MD, Principal investigator, BC Women's Hospital/UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527786
- Sponsor's protocol ID
- PRISTIQ IOP # 3151A1-44
- Status last verified
- Jan 2015
- First submitted
- 14 Oct 2010
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
- ClinicalTrials.gov ID
- NCT01527786
- Acronym / sponsor ID
- PRISTIQ IOP # 3151A1-44
- Conditions
- Depression
- Keywords
- Major Depressive Disorder, Postpartum Onset
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BC Women's Hospital & Health CentreUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Feb 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.
Postpartum depressed women suffer from functional impairment in their mood, thoughts, cognition and physical well being leading to poor motivation, bonding difficulties, decreased productivity, conflict and neglect. Moderate/ severe depression responds best to a combination of antidepressants and counseling. This study will estimate the proportion of women who return to functionality after treatment with Desvenlafaxine and examine the differential impact of change in depression and anxiety symptoms on functionality over twelve weeks. Depression and anxiety symptoms will be monitored through six mood questionnaires; functional recovery will be monitored through a simple self-report questionnaire at each visit.
Detailed description
Women will be recruited through a tertiary level care program and advertisements in BC Children's \& Women's Hospital as well as St.Paul's Hospital, Vancouver, B.C., Canada. If deemed eligible for the study (meeting a diagnosis of postpartum depression with or without comorbid anxiety disorder) and the potential participant agrees to participate, consent will be signed. The participant will return on a bi-weekly basis for study visits, where mood and anxiety will be monitored, in addition to blood pressure and weight. Starting dose of Desvenlafaxine is 50mg, and this can be titrated to 100mg/per day if needed. Questionnaires will assess depression symptoms, anxiety symptoms, quality of life, panic disorder, obsessive-compulsive disorder and generalized anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNRI treatment | Experimental | Drug: DesvenlafaxineParticipants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI). |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- To be able to read and write English.
- Written informed consent before initiation of any study related procedures.
- Diagnosis of Major Depressive Disorder (MDD) with onset of depressive symptoms within 12 months of delivery.
- Diagnosis of additional comorbid panic, generalized anxiety or obsessive compulsive disorder, if they occur in addition to MDD.
- Patients will be required to have a score of (greater than or equal than) 25 on the Montgomery-Asberg Depression Rating Scale (MADRS) at enrolment (moderate to severe depression).
Key exclusion criteria (20 listed)
- The patient is currently breastfeeding or pregnant.
- The patient has a significant risk of suicide according to investigator's opinion or presents a score ³5 on item 10 (suicidal thoughts) of the MADRS.
- The patient meets DSM-IV-TR criteria for:
- The patient uses the following disallowed recent or concomitant medication within the specified time periods:
- The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy elsewhere, or plans to initiate such therapy during the study outside of the clinic.
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 |
|---|---|---|
| Desvenlafaxine50mg-100mg everyday for 12 weeks over 7 study visits | Drug | SNRI treatment |
Primary outcome
Sheehan Disability Scale (SDS)
Time frame: Baseline
The Sheehan Disability Scale (SDS), which measures global functional impairment, as well as the individual score on each subscale (work/school; social life; family life/home responsibilities). To provide estimates for further studies, the mean change in score will be estimated with 95% confidence limits as a measure of variability. In addition, the proportion of subjects showing a change of more than clinically important change of more than 5 points will be estimated.
Sheehan Disability Scale (SDS)
Time frame: 12 weeks
The Sheehan Disability Scale (SDS), which measures global functional impairment, as well as the individual score on each subscale (work/school; social life; family life/home responsibilities). To provide estimates for further studies, the mean change in score will be estimated with 95% confidence limits as a measure of variability. In addition, the proportion of subjects showing a change of more than clinically important change of more than 5 points will be estimated.
3 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale- Anxiety (HAM-A), the Yale-Brown Obsessive Compulsive Scale (YBOCS), the Panic Disorder Severity Scale (PDSS), and the Penn Sate Worry Questionnaire (PSWQ).
Time frame: Baseline
Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale- Anxiety (HAM-A), the Yale-Brown Obsessive Compulsive Scale (YBOCS), the Panic Disorder Severity Scale (PDSS), and the Penn Sate Worry Questionnaire (PSWQ).
Time frame: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale- Anxiety (HAM-A), the Yale-Brown Obsessive Compulsive Scale (YBOCS), the Panic Disorder Severity Scale (PDSS), and the Penn Sate Worry Questionnaire (PSWQ).
Time frame: 12 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 28 Jan 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.
Shaila Misri, MD principal investigator
BC Women's Hospital/UBC
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 Desvenlafaxine in people with Depression, run by BC Women's Hospital & Health Centre 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 10 inclusion and 20 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 28 Jan 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. 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?
Sheehan Disability Scale (SDS) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 28 Jan 2015.