Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by BC Women's Hospital & Health Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Shaila Misri, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier:
NCT01527786
First received: October 14, 2010
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Desvenlafaxine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine

Resource links provided by NLM:


Further study details as provided by BC Women's Hospital & Health Centre:

Primary Outcome Measures:
  • Sheehan Disability Scale (SDS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNRI treatment
Participants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI).
Drug: Desvenlafaxine
50mg-100mg everyday for 12 weeks over 7 study visits

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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. To be able to read and write English.
  2. Written informed consent before initiation of any study related procedures.
  3. Diagnosis of Major Depressive Disorder (MDD) with onset of depressive symptoms within 12 months of delivery.
  4. Diagnosis of additional comorbid panic, generalized anxiety or obsessive compulsive disorder, if they occur in addition to MDD.
  5. 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).
  6. Patients need to be referred by their usual treating primary care physician.
  7. 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.
  8. Patient does not wish to pursue CBT elsewhere.
  9. The patient is using an appropriate method of contraception, which may include abstinence, in order to avoid pregnancy during the study.
  10. The patient is not currently breastfeeding.

Exclusion Criteria:

  1. The patient is currently breastfeeding or pregnant.
  2. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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.
  7. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527786

Contacts
Contact: Shaila Misri, MD 604-875-2025 ext 6471 smisri@cw.bc.ca
Contact: Jasmin Abizadeh, BA 604-875-3525 jabizadeh@cw.bc.ca

Locations
Canada, British Columbia
BC Women's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Jasmin Abizadeh, BA    602-875-3525    jabizadeh@cw.bc.ca   
Principal Investigator: Shaila Misri, MD         
Sponsors and Collaborators
BC Women's Hospital & Health Centre
Investigators
Principal Investigator: Shaila Misri, MD BC Women's Hospital/UBC
  More Information

No publications provided

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
Study First Received: October 14, 2010
Last Updated: February 3, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014