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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNRI treatment | Experimental | Participants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine | Drug | 50mg-100mg everyday for 12 weeks over 7 study visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Shaila Misri, MD | BC Women's Hospital/UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Women's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| 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. | 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. | 12 weeks |
| D001523 |
| Mental Disorders |
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |