SYNERGIC EFFECTS OF OXYTOCIN AND PSYCHOTHERAPY IN POSTPARTUM DEPRESSION. RANDOMIZED CONTROLLED STUDY. - POSTPARTUM DEPRESSION: OXYTOCIN AND PSYCHOTHERAPY

Conditions: Postpartum depression.
MedDRA version: 9.1Level: LLTClassification code 10036235Term: Postnatal blues

Registration Number: EUCTR2008-001913-51-IT

Lead Sponsor: ISTITUTO PER L'INFANZIA BURLO GAROFOLO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

The study will include all new become mothers who showed (during the first week after the birth of their child) to their gynecologict or paediatrician one or more of the risk factors of Postpartum Depression, outlined in Beck (2003).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Only mothers with no psychotic features and with unipolar depression shall be included.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of the administration of intranasal oxytocin in conjunction with psychotherapy in women with postpartum depression.;Secondary Objective: To evaluate the differential effect of introspective versus prescriptive psychotherapy.;Primary end point(s): Target group A (oxytocin + introspective psychotherapy) is expected to show the greater combined effect over group (placebo + prescriptive psychotherapy, i.e., a much more rapid and statistically significant improvements in the Postpartum Depression related parameters in the direction of a well-being state, a more enduring and stable regaining of pleasurable experiences).

Secondary Outcome Measures