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Aripiprazole and Resistant Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386086
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : March 17, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):
Verinder Sharma, Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Postpartum Depression Drug: aripiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmentation Therapy of Resistant Postpartum Depression With Aripiprazole
Study Start Date : June 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: 6 weeks ]
    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 :
  1. Udvalg for Kliniske Undersogelser Scale [ Time Frame: 6 weeks ]
    To assess the tolerability of aripirazole in women with resistant postpartum depression as assessed by the Udvalg for Kliniske Undersogelser Scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01386086

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Canada, Ontario
Regional Mental Health Care
London, Ontario, Canada, N6A4H1
Sponsors and Collaborators
Lawson Health Research Institute
Bristol-Myers Squibb
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Principal Investigator: Verinder Sharma, MBBS University of Western Ontario, Canada

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Responsible Party: Verinder Sharma, Psychiatrist, Lawson Health Research Institute Identifier: NCT01386086    
Other Study ID Numbers: CN138-623
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Verinder Sharma, Lawson Health Research Institute:
adjunctive therapy
mood stabilizers
major depressive disorder
Augmentation therapy
Additional relevant MeSH terms:
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Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists