E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Social Anxiety Disorder (Social Phobia) |
Sociale Angststoornis (Social Phobia) |
|
E.1.1.1 | Medical condition in easily understood language |
Social Anxiety |
Sociale angst |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041250 |
E.1.2 | Term | Social phobia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of testosterone enhanced exposure therapy for social anxiety disorder. |
Primaire doelstelling is de toegevoegde waarde van testosteron bij exposuretherapie voor sociale angststooornis te onderzoeken. |
|
E.2.2 | Secondary objectives of the trial |
To assess which variables predict outcome. |
Predicerende factoren identificeren. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Woman, 18-45 years old
- Social Anxiety Disorder (SAD) as established with a structured interview (MINI)
- Self reported SAD symptoms of at least moderate severity (score > 30 on the Liebowitz Social Anxiety Scale)
|
- Vrouw, tussen de 18 en 45 jaar
- Diagnose sociale fobie, zoals vastgesteld met een gestructureerd klinisch interview (MINI)
- Zelfgerapporteerde sociale angstsymptomen van minimaal matige ernst (score van >30 op de Liebowitz Social Anxiety Scale) |
|
E.4 | Principal exclusion criteria |
- Psychosis or delusion disorders (current or in the past)
- Suicidality
- Mental retardation
- Substance abuse or dependence or alcohol abuse or dependence
- Somatic illness
- Women of childbearing potential that are not willing to use an active form of birth-control during the trial
- Pregnancy or lactation
- Infertility
- Antipsychotic medication
- Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment.
- Insufficient ability to speak and write Dutch
|
- Psychotische of waanstoornis (huidig of in de voorgeschiedenis)
- Suicidaliteit
- Zwakbegaafdheid
- Middelen misbruik of afhankelijkheid of alcohol misbruik of afhankelijkheid
- Somatische aandoeningen
- Antipsychotische medicatie
- Het gebruik van antidepressiva of benzodiazepines is geen exclusiecriterium, maar deelnemers moeten minimaal zes weken voor inclusie op een stabiele dosering zitten.
- Vrouwen in de vruchtbare leeftijd die niet bereid zijn een actieve vorm van anticonceptie te gebruiken tijdens de trial
- Zwangerschap of borstvoeding
- Onvruchtbaarheid
- Onvoldoende beheersing van de Nederlandse taal |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Our main outcome is reduction of social anxiety disorder symptoms, as assessed by the Liebowitz Social Anxiety Scale (LSAS). |
Primaire uitkomstmaat is reductie van sociale angstklachten, zoals gemeten met de Liebowitz Sociale Anxiety Scale (LSAS). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Posttreatment, 1 month FU |
Na de behandeling, en 1 maand follow-up |
|
E.5.2 | Secondary end point(s) |
Subsequently, outcome will be assessed by other self-report questionnaires (Social Phobia Anxiety Inventory (SPAI) and Beck Depression Inventory (BDI). In addition, we will assess automatic socio-anxiolytic behavior tendencies by means of implicit measures. |
Daarnaast zullen we de uitkomst evalueren aan de hand van andere zelfrapportage instrumenten (Social Phobia Anxiety Inventory (SPAI) and Beck Depression Inventory (BDI). Voorts bekijken we automatische sociaal-angstige gedragsneigingen aan de hand van impliciete maten. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Posttreatment, 1 month FU |
Na de behandeling en 1 maand follow-up |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial ends when the last subject finishes her follow-up assigment. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |