Development of Dietary Supplements for Mood Symptoms in Postpartum
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M5T 1R8
- Centre for Addiciton and Mental Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 to 45
- The subject, as reported by them, should be in a good health.
- The subject is not taking any medication.
- The subject is not taking any investigational medicinal product within 8 weeks.
- BMI 19 to 40 (kg/m2)
- Resting pulse between 45 and 100 bpm
- Systolic blood pressure between 91 and 139 mmHg (inclusive)
- Diastolic blood pressure between 51 and 90 mmHg (inclusive)
Exclusion Criteria:
- The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for DSM-IV interview.
- Substance abuse disorder
- Subjects who have been smoking in the past 5 years.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Postpartum with crying spells-Full dose
Healthy women who are within the first 18 months postpartum and have crying spells but do not have major depression. The effect of the dietary supplement in reducing sadness in this group will be assessed. Intervention: Full dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Expérimental: Day-5 postpartum - Full dose
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the dietary supplement consumption is being done after delivery and during postpartum. Intervention: Full dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Expérimental: Day-5 postpartum - Half dose
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the proposed dietary supplement consumption, is being done after delivery and during postpartum. Intervention: Half dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Expérimental: Day-5 postpartum - Quarter dose
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving the proposed dietary supplement consumption, is being done after delivery and during postpartum. Intervention: Quarter dose dietary supplement Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
|
Autre: Day-5 postpartum - Control
Healthy women on day-5 postpartum. This group is recruited during pregnancy but the main study day, involving a control supplement consumption, is being done after delivery and during postpartum. Intervention: Control protein to compare with Motherwell |
The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Visual Analog Scale (VAS)
Délai: Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the VAS will be administered before and after sad mood indcution and compared
|
VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad.
The change in VAS before versus after sad mood induction is the change score in VAS.
The change score on the day with active dietary supplement is compare to the change score of the subjects who have not received any supplement and have been recently recruited
|
Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the VAS will be administered before and after sad mood indcution and compared
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Profile of Mood States (POMS) Scores
Délai: Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the POMS will be administered before and after sad mood indcution and compared
|
The POMS contains 65 adjectives rated by participants on a 5-point scale.
Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion.
|
Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the POMS will be administered before and after sad mood indcution and compared
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jeffrey H Meyer, MD,PhD,FRCPC, Research Imaging Centre, Centre for Addiction and Mental Health
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 112/2013
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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