Postpartum depression. MedDRA version: 9.1 Level: LLT Classification code 10036235 Term: Postnatal blues
Conditions
Interventions
Trade Name: SYNTOCINON SPRAY
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Oxytocin
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 16-
P
Sponsors
ISTITUTO PER L'INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Only mothers with no psychotic features and with unipolar depression shall be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Outcome results
None listed