The Effect of Oral Contraceptive Onset on Emotion Regulation in Adolescence

Phase 4

Conditions: sub-klinische depressie en angst scores en emotieregulatie metingen
anxiety and depression symptoms
mood problems
10027946

Registration Number: NL-OMON50830

Lead Sponsor: niversiteit Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 126

Inclusion Criteria

• Healthy (no somatic or psychiatric diagnoses)
• 14-18 years
• Body Mass Index (BMI) between 14-30
• Regular menstrual cycle (25-32 days)
• Pillgroup: girls who will start the use of the oral contraceptive pill for
the first time or after a break of minimum 6 months (assuming the use of the
standard prescription of ethinylestradiol/levonorgestrel 0,03/0,15 mg; a pill
with androgenic function, however other androgenic pills will also be included)
• Control group: girls who have never taken hormonal contraceptives or not
taken hormonal contraceptives for at least the past 6 months

Exclusion Criteria

• Starting an oral contraceptive pill with anti-androgenic function after the
first lab visit
• Use of hormones 6 months before study onset
• Use of psychotropic medication/drugs three months before study onset
• Pregnant or breastfeeding
• Hormone disorders
• Endometriosis
• Polycystic ovarian syndrome (PCOS)
• Current or previous diagnosed psychiatric or neurological disorders
(self-report)
• Participants will be asked to prevent intake of marijuana (>48h), alcohol
(>24h) and caffeine (>2h) before onset of the experiment.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are the measurements regarding emotion regulation<br /><br>that are associated with fear and pill use in adults: the extent of fear<br /><br>acquisition and extinction by subjective measures and skin conductance (during<br /><br>the emotion regulation experiments).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The other study parameters include the Late Positive Potential (LPP) as a<br /><br>neural marker and electromyographie (EMG) as a physical marker for emotional<br /><br>reactivity that is modulated by emotion regulation (during the emotion<br /><br>regulation experiments) , and cortisol, self-evaluation and task performance<br /><br>changes after induced psychosocial stress (during the stress experiments), and<br /><br>mood questionnaires. These different study parameters are included to form a<br /><br>comprehensive view on the effects of the pill on neural, physiological and<br /><br>psychological processes underlying depression and anxiety in adolescents.</p><br>