Pregnant women, depressive symptoms, anxiety, antidepressants, SSRI, tapering of medication
Conditions
Interventions
After informed consent, women will be randomly allocated into two groups:
1) Preventive cognitive therapy with gradual, guided discontinuation of SSRI under clinical management (intervention group)
2) Continuation of SSRI (control group).
Sponsors
ErasmusMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Less than 16 weeks pregnant; 2. SSRI use for depressive disorder.
Exclusion criteria
Exclusion criteria: 1. Insufficient proficiency in Dutch or English; 2. Multiple pregnancies (because of increased risk for adverse birth outcomes that might confound statistical analyses); 3. Severe medical conditions that involve treatment decisions overriding research participation; 4. Current relapse of depression after previous attempts to taper SSRIs; 5. Current other psychiatric disorders (i.e. psychosis, bipolar disorder, severe obsessive-compulsive disorder, substance abuse, suicidality and/or serious self-harm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk (cumulative incidence) of relapse of maternal depressive disorder (as defined by the Structured Clinical Interview for DSM disorders) during pregnancy and up to 3 months postnatal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mother: 1. Time to relapse of maternal depressive disorder during pregnancy and up to 3 months after delivery; 2. SSRI use and dosage, psychiatric co-medication (e.g. benzodiazepines), adherence to preventive cognitive therapy; 3. Side effects of (tapering of) medication (checklist); 4. Hazardous behavior (e.g. use of alcohol/drugs or suicidality); 5. Stress, depressive symptoms,anxiety, and childhood trauma; 6. Direct medical costs (until 3 months postpartum), indirect costs (with adjustment for pregnancy leave period), quality of life effects mother; 7. Obstetric complications during pregnancy and delivery (spontaneous abortion, referral midwife to obstetrician, preeclampsia [ISSHP definition], assisted delivery, induced labour for maternal indication [premature, term delivery], epidural anaesthesia for pain, caesarean section). Child: 1. Specific: child condition at birth (poor neonatal adaptation defined as: 5-min Apgar <7 and/or admission to pediatric ward/NICU); 2. General: gestational age at birth, birth weight, head circumference at birth; these measures also expressed as deviance scores/percentiles; 3. Neuromotor development (General Movements [GM]); 4. Child behavior (Child Behavior Check List at 18 months; parental and caregiver report); 5. Child development as collected from routine data of Centres of Childhood (CJG) up to 24 months after delivery; 6. Direct medical costs, quality of life (proxy). Other study parameters: 1. Baseline: age, ethnicity, level of education, marital status, parity, unwanted/unplanned pregnancy, Body Mass Index (BMI), somatic conditions (if not exclusion criteria), medication use and substance use (smoking, alcohol, drug); 2. Maternal (epi)genetic and pharmacogenetic markers: e.g. 5HTTLPR, BDNF, FKBP5, TREK1, COMT, CRH1, CYP2D6 and CRHBP) (Kupfer, 2012)40; 3. Child (epi)genetic markers: e.g. NR3C1, HTR2A; 4. Maternal hair cortisol will be used as a validated biomarker for maternal and child cortisol exposure | — |
Contacts
Public ContactN. Molenaar
Antwoordnummer 55, 3000 WB, Rotterdam
Outcome results
None listed