postpartum mood disorder
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in the OPPER study, a subject must meet all of the following criteria (inclusion criteria OPPER study):, Inclusion criteria patients: • Age: 18-45 • Postpartum onset psychosis, mania or severe depression • Written informed consent, Also, parents will be asked for consent to include their children in our study (between the age of 2 and 5 years). , Inclusion criteria healthy control: • Age: 18-45 • No history or current DSM-V diagnosis • Written informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in the OPPER study (exclusion criteria OPPER study): • Patients whom are incapable to understand the information and to give informed consent. And patients whom are unable to read or write. • Drug/ alcohol dependence last 3 months • Mental retardation (IQ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to investigate the underlying neurobiology of first-onset PPMD using longitudinal neuroimaging. Brain imaging will be performed during both the acute episode (median 4 weeks postpartum) and after full remission (12 months after onset). All MRI scans will be made by a trained researcher and trained research assistant. The scanning protocol contains a whole-brain structural MRI examination combined with Diffusion Tensor Imaging (DTI), functional MRI (fMRI) scans and Magnetic Resonance Spectroscopy (MRS). Because our previous research showed a possible auto-immune related cause of postpartum mood disorders, we expect changes in white matter. Therefore our primary measure will be white matter integrity, measured by the fractional anisotropy (FA). Fractional anisotropy is the most-widely used DTI-based index in brain research. Fractional anisotropy provides a gray-scale, 2D map, enhancing diffusion anisotropy difference with intensity limits between zero and one. In white matter, the anisotropy is high (approaching unity in most ordered areas), reflecting fast diffusivity along the fibers and slow diffusivity perpendicular to them. In gray matter and CSF, the anisotropy approaches zero as the diffusivity is similar in all directions. White matter abnormalities lead to a decrease in fractional anisotropy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the longitudinal course of women with first-onset PPMD and predictive factors for the longitudinal disease course (and thus for the need for long-term maintenance therapy). Our main variable of interest is relapse. Relapse will be defined as the occurrence of any affective or psychotic symptoms fulfilling DSM-IV-R criteria and severe enough to warrant treatment. We will make a clear distinction of relapse after a subsequent pregnancy versus a relapse outside the postpartum period, thereby enabling the distinction between women with episodes of affective psychosis entirely limited to the postpartum period (PPMD only) versus those with a lifelong mood disorder. Our previous showed that overall relapse risk for women with only postpartum-onset psychoses is 31% (95% CI=22, 42) as derived from 13 studies, 595 deliveries, and 528 patients. The risk of a postpartum episode (affective psychosis, mania, mixed episode, or relapse requiring hospitalization) was significantly higher in patients with a history of postpartum psychosis (29%, 95% CI=20, 41) compared to women with more chronic forms of bipolar disorder. Further, in stark contrast to the high rates of relapse in women with bipolar disorder during pregnancy, women with a history of psychosis limited to the postpartum period are not at elevated risk of psychiatric episodes during pregnancy. We hypothesize that predictive factors for the longitudinal course might include: a. timing of onset b. genetic vulnerability c. immune related vulnerability Timing of onset The onset and severity of PPMD in the early postpartum period is not only of diagnostic importance, but it may also well predict the likelihood of subsequent conversion to a lifelong mood disorder. Several clinical experts in the field have discussed the perspective that very early PPMD is more likely to have a bipolar diathesis, especially if prominent manic symptoms are present. In contrast, from a neu | — |
Countries
Netherlands
Outcome results
None listed