Lexapro in the Treatment of Patients With Postpartum Depression

NCT00277108 | Completed

• 1 other identifier: LXP-MD80
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the treatment of postpartum depression.

Conditions

Postpartum Depression

Keywords

postpartum depression; postnatal depression; PPD

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.

Secondary Outcomes (1)

• A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.

Interventions

Escitalopram (Lexapro) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological mothers of infants ages 2 weeks to 12 months of age
• Age 18 and over
• Must understand and speak English well enough to read and provide written informed consent, complete written questionnaires and complete the SCID.
• The primary Axis I diagnosis, as determined by the SCID, must meet the DSM-IV criteria for Unipolar Major Depression, Single or Recurrent, Moderate to Severe. Onset of depression must occur within pregnancy to the first 12 months following childbirth. Concurrent diagnoses of anxiety disorders including obsessive compulsive disorder, panic disorder, specific phobias, generalized anxiety disorder, and post-traumatic stress disorder will be allowed if they are not the primary diagnosis.
• The subject must receive a MADRS total score of \> 22 at screening and at the baseline visit and a total score of \>17 on the HAM-D at the baseline visit.
• The subject must be able to comply with instructions and be capable of participating in an 8 week study.

You may not qualify if:

• Under 18 years of age.
• Subjects who are breastfeeding.
• History of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia.
• History of any DSM-IV Axis II diagnosis, which in the investigator's opinion, would interfere with compliance of the protocol.
• History of alcohol or drug abuse or dependence in the last year.
• Treatment with other psychotropic drugs except permissible concomitants.
• Current severe psychiatric symptoms requiring psychiatric hospitalization, current psychosis or suicidal, homicidal potential.
• History of intolerance to or hypersensitivity to Citalopram.
• Subjects whose depressions are known to be unresponsive to Escitalopram.
• Subjects who are pregnant or who intend to become pregnant during the course of the study.
• Subjects who have any medical or neurological disorder that in the investigators' opinion may contribute to depression.
• Subjects who have started psychotherapy within three months prior to baseline or who intend to start psychotherapy during the study.

Sponsors & Collaborators

• University of Rochester: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Linda H Chaudron, MD, MS

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: February 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: November 6, 2008

Record last verified: 2008-11

Locations

US (1)