Aripiprazole and Resistant Postpartum Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01386086
First received: April 21, 2011
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

Currently there are no controlled data on the management of postpartum depression that fails to respond to adequate antidepressant therapy. The investigators recently reported that a large number of patients responded to the addition of atypical neuroleptics after having failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective in patients with resistant depression but it has not been studied in patients with resistant postpartum depression. The investigators propose to conduct a 6 week open-label study to assess the effectiveness and tolerability of aripiprazole used adjunctively to antidepressants in patients with resistant postpartum depression.


Condition Intervention Phase
Postpartum Depression
Drug: aripiprazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Augmentation Therapy of Resistant Postpartum Depression With Aripiprazole

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To assess the effectiveness of the addition of aripiprazole in the treatment of resistant postpartum depression as measured by the change in mean scores on the Montgomery Asberg Depression Rating Scale between baseline and the study termination endpoint.


Secondary Outcome Measures:
  • Udvalg for Kliniske Undersogelser Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    To assess the tolerability of aripirazole in women with resistant postpartum depression as assessed by the Udvalg for Kliniske Undersogelser Scale.


Estimated Enrollment: 10
Study Start Date: June 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
aripiprazole used adjunctively to antidepressants in patients with resistant postpartum depression
Drug: aripiprazole
The starting dose of aripiprazole will be 2 mg and the dose adjusted to a maximum of 15 daily

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Euthyroid outpatients aged 18 to 45 years of age
  • A DSM-IV diagnosis of major depressive disorder with episode onset within 3 months of delivery
  • A 17-item HAM-D score of 18 or more
  • Inadequate response to at least one antidepressant drug - defined as a <50% reduction in severity of depression for a duration of >6 weeks ( > than 8 weeks for fluoxetine), determined by the Massachusetts General Hospital Antidepressant Response Questionnaire. Patients having a score of 18 or more on the 17-item HAM-D will be eligible to participate in the study. The primary efficacy endpoint will be mean change in MADRS score, and the secondary endpoint will be mean change in the HAM-D score

    >For patients on psychotropic drugs (other than antidepressants) prior there will be a washout period of two weeks

  • Ability to understand English and provide informed consent
  • Women who delivered a healthy baby close to term (37-42 weeks)
  • Use of adequate contraception > Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.

WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal.

Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.

WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days before the start of the investigational product.

A subject's male partner of fathering potential must use an adequate method of contraception to avoid conception throughout the study [and for at least 4 weeks after the last dose of study drug] to minimize the risk of pregnancy.

Exclusion Criteria:

  • Women with onset of major depressive disorder during pregnancy
  • Presence of another current Axis I disorder such as bipolar disorder, psychotic disorder or obsessive compulsive disorder or a history of psychosis or a history of post-partum mood disorder with psychotic features
  • Presence of psychotic symptoms
  • History of alcohol or substance abuse within the 12 months before screening
  • Any Axis II diagnosis suggestive of likely non-compliance with study requirement or non-responsiveness to pharmacotherapy.
  • Women receiving psychotherapy
  • Women receiving psychotropic drugs not allowed in the study protocol
  • Use of quinolone antibiotics such as ciprofloxacin
  • Significant medical illness such as end stage renal disease, uncontrolled narrow angle glaucoma and liver disease
  • Women considered at high risk for suicide-those that are actively suicidal or have a score of ≥ 3 on item #3 on the 17-item HAMD; or women who, in the opinion of the Investigator, are deemed to be at risk of causing harm to the baby
  • Women who are nursing/breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386086

Contacts
Contact: Verinder Sharma, MBBS 519-455-5110 ext 47600 vsharma@uwo.ca

Locations
Canada, Ontario
Regional Mental Health Care Recruiting
London, Ontario, Canada, N6A4H1
Contact: Verinder Sharma, MBBS    519-455-5110 ext 47600    vsharma@uwo.ca   
Principal Investigator: Verinder Sharma, MBBS         
Sponsors and Collaborators
Lawson Health Research Institute
Bristol-Myers Squibb
Investigators
Principal Investigator: Verinder Sharma, MBBS University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. Verinder Sharma, University of Western Ontario
ClinicalTrials.gov Identifier: NCT01386086     History of Changes
Other Study ID Numbers: CN138-623
Study First Received: April 21, 2011
Last Updated: June 29, 2011
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Aripiprazole
adjunctive therapy
mood stabilizers
major depressive disorder
postpartum
Augmentation therapy
resistant

Additional relevant MeSH terms:
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 23, 2014