NCT00989053

Brief Summary

Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore, stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was suggested to be involved in the process. Treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. The investigators suggest to study the efficacy of antidepressant treatment in women undergoing IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

October 1, 2009

Last Update Submit

October 1, 2009

Conditions

DepressionAnxietyIn Vitro Fertilization

Keywords

depressionanxietystressantidepressant therapySSRIinfertilityin vitro fertilization (IVF)immunological factorsdepressive and anxiety symptoms in women undergoing IVF treatment

Outcome Measures

Primary Outcomes (1)

  • positive blood βHCG

    2 months from date of signing informed consent

Secondary Outcomes (1)

  • psychiatric evaluation questionnaires

    2 months

Study Arms (2)

escitalopram

ACTIVE COMPARATOR
Drug: escitalopramDrug: placebo

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

escitalopramDRUG

10 mg/d for a duration of 8 weeks

escitalopram
placeboDRUG

1 pill per day for 8 weeks

escitalopramplacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women 18 - 45 y.o.
  • A score higher then 45 on the Zung Self-Rating Anxiety Scale or a score higher then 16 on the Center for Epidemiologic Studies Depression Scale
  • Understanding of Hebrew
  • Willing to sign the informed consent

You may not qualify if:

  • An axis I DSM IVTR diagnosis other then a depressive, adjustment or anxiety disorder
  • Suicidal ideation
  • Current treatment with antidepressant medication
  • Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
  • Alcoholism or drug abuse and dependence
  • Past severe side effects to SSRIs
  • Failed IVF (4 trials of good quality embryo reinstatement without achieving pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersInfertility

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

IL(1)