Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
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ClinicalTrials.gov Identifier: NCT01527786 |
Recruitment Status
:
Completed
First Posted
: February 7, 2012
Last Update Posted
: January 28, 2015
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Condition or disease | Intervention/treatment | Phase |
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Depression | Drug: Desvenlafaxine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: SNRI treatment
Participants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI).
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Drug: Desvenlafaxine
50mg-100mg everyday for 12 weeks over 7 study visits
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- 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.
- 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 ]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.
- 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 ]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.
- 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 ]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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Ages Eligible for Study: | 19 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
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.
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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,
- current drug or alcohol abuse or dependence,
- current eating disorder (anorexia or bulimia).
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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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527786
Canada, British Columbia | |
BC Women's Hospital | |
Vancouver, British Columbia, Canada, V6H 3N1 |
Principal Investigator: | Shaila Misri, MD | BC Women's Hospital/UBC |
Responsible Party: | Dr. Shaila Misri, Dr., BC Women's Hospital & Health Centre |
ClinicalTrials.gov Identifier: | NCT01527786 History of Changes |
Other Study ID Numbers: |
PRISTIQ IOP # 3151A1-44 |
First Posted: | February 7, 2012 Key Record Dates |
Last Update Posted: | January 28, 2015 |
Last Verified: | January 2015 |
Keywords provided by Dr. Shaila Misri, BC Women's Hospital & Health Centre:
Major Depressive Disorder, Postpartum Onset |
Additional relevant MeSH terms:
Depression Depressive Disorder Depression, Postpartum Behavioral Symptoms Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications Desvenlafaxine Succinate |
Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs |