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Trial record 5 of 2393 for:    depression AND (woman OR women OR female)

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
Sponsor:
Information provided by (Responsible Party):
Dr. Shaila Misri, BC Women's Hospital & Health Centre

Tracking Information
First Submitted Date  ICMJE October 14, 2010
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date January 28, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01527786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
Official Title  ICMJE A Pilot Study of Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
Brief 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. 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 Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Drug: Desvenlafaxine
50mg-100mg everyday for 12 weeks over 7 study visits
Study Arms Experimental: SNRI treatment
Participants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI).
Intervention: Drug: Desvenlafaxine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2015)
25
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2012)
20
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01527786
Other Study ID Numbers  ICMJE PRISTIQ IOP # 3151A1-44
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Shaila Misri, BC Women's Hospital & Health Centre
Study Sponsor  ICMJE BC Women's Hospital & Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaila Misri, MD BC Women's Hospital/UBC
PRS Account BC Women's Hospital & Health Centre
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP