Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT07127458
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anxiety and Depression in Adolescent PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beck Depression Inventory', 'timeFrame': '6 Months', 'description': 'Change in Beck Depression Inventory Score After 6 Months of Oral Contraceptive Use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome (PCOS)', 'Adolescents', 'Anxiety and Depression'], 'conditions': ['PCOS (Polycystic Ovary Syndrome)']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in adolescent females, often accompanied by psychological symptoms such as anxiety and depression. These conditions are frequently underdiagnosed and untreated. This study aims to determine the prevalence of anxiety and depression in adolescents with PCOS and to assess changes following oral contraceptive use.', 'detailedDescription': 'Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age, characterized by heterogeneous complications. It is increasingly prevalent among adolescent females today. Women with PCOS may experience infrequent or prolonged menstrual periods, excessive hair growth, acne, and obesity. The rising prevalence of PCOS in the general population affects approximately 5-10% of women of reproductive age worldwide (1). A significant proportion of women with PCOS-particularly adolescent girls-experience major depressive disorder. Although the exact cause of PCOS remains unknown, early diagnosis and treatment, along with weight loss, can reduce the risk of long-term complications. Depression and anxiety are common in women with PCOS; however, their frequency has often been overlooked, leaving many cases untreated (2). In addition to physical symptoms, various mental health problems are also associated with PCOS (3). The diagnosis of PCOS is established when at least two of the following criteria are present: amenorrhea/oligomenorrhea, hyperandrogenism (clinical or biochemical), and a polycystic ovarian appearance on ultrasound (4). Psychosocial problems are particularly common among obese adolescents and those with excessive hair growth.\n\nThe rationale of this study is to investigate the prevalence of this often-overlooked comorbidity and to evaluate changes following OCS (oral contraceptive) use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 15 and 19 years\n* Diagnosis of adolescent polycystic ovary syndrome (PCOS)\n\nExclusion Criteria:\n\n* Severe reading or comprehension difficulties\n* Severe hearing impairment\n* Current use of hormone therapy\n* Presence of a virilizing tumor\n* Major psychiatric disorders such as schizophrenia, bipolar disorder, or dissociative disorder'}, 'identificationModule': {'nctId': 'NCT07127458', 'briefTitle': 'Anxiety and Depression in Adolescent PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Prevalence of Anxiety and Depression in Adolescents With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'A-PCOS-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adolescents with Polycystic Ovary Syndrome', 'description': 'Adolescent patients with PCOS will be identified, and the prevalence of anxiety and depression will be assessed. Oral contraceptive therapy will be initiated, and patients will be re-evaluated after 6 months.', 'interventionNames': ['Drug: Adolescent PCOS group receiving oral contraceptives']}], 'interventions': [{'name': 'Adolescent PCOS group receiving oral contraceptives', 'type': 'DRUG', 'description': 'Participants diagnosed with polycystic ovary syndrome (PCOS) during adolescence will receive a combined oral contraceptive (ethinylestradiol 30 µg + drospirenone 3 mg) once daily for six consecutive months. The intervention aims to regulate menstrual cycles, reduce hyperandrogenic symptoms, and evaluate changes in anxiety and depression scores over time.', 'armGroupLabels': ['Adolescents with Polycystic Ovary Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35665', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sabahattin A Arı, Associate Professor', 'role': 'CONTACT', 'email': 's.anil.ari.md@gmail.com', 'phone': '+905547139994'}], 'facility': 'Izmir Bakircay University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Sabahattin A Arı, Associate Professor', 'role': 'CONTACT', 'email': 's.anil.ari.md@gmail.com', 'phone': '+905547139994'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sabahattin Anıl Arı', 'investigatorAffiliation': 'Ege University'}}}}