Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine

NCT01527786 | Completed Phase 3

• 1 other identifier: PRISTIQ IOP # 3151A1-44
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Major Depressive Disorder, Postpartum Onset

Outcome Measures

Primary Outcomes (2)

• 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

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).

  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).

  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).

  12 weeks

Study Arms (1)

SNRI treatment

EXPERIMENTAL

Participants are undergoing pharmacotherapy treatment with Desvenlafaxine (SNRI).

Drug: Desvenlafaxine

Interventions

Desvenlafaxine DRUG

50mg-100mg everyday for 12 weeks over 7 study visits

SNRI treatment

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• BC Women's Hospital & Health Centre: lead

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• Shaila Misri, MD

  BC Women's Hospital/UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: February 7, 2012
• Study Start: November 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

CA (1)