Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 10:58 AM
Study NCT ID:
NCT07333027
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lonely in Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples: EDTA and Serum collection --\\> blood, plasma, serum, cells (PBMCs, Leukocyten) Salvia samples: Salivette® Cortisol Stool samples: stool collection tubes with stabilizer --\\> microbiome analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-31', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood markers (metabolic, LDL)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'LDL cholesterin \\[mg/dl or mmol/l\\], higher values (\\> 100 mg/dl or \\> 2.6 mmol/l) represent unfavorable metabolic risk'}, {'measure': 'Blood markers (metabolic, HDL)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'HDL cholesterin \\[mg/dl or mmol/l), \\< 40 mg/dl men and \\< 50 mg/dl women represents unfavorable metabolic risk, ≥ 40 mg/dl men ≥ 50 mg/dl women acceptable, ≥ 60 mg/dl protective'}, {'measure': 'Blood markers (metabolic, HbA1c)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'HbA1c \\[%\\], higher values (\\> 5.7%) represent unfavorable metabolic risk'}, {'measure': 'Blood markers (Sphingolipid metabolism)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Sphingolipid metabolism enzyme activity of secretory acid sphingomyelinase (S-ASM) \\[nmol/mL/h/µL\\], higher leveles represent more inflammation/apoptosis enzyme activity of neutral acid sphingomyelinase (N-ASM) \\[nmol/mL/h/µL\\], higher levels represent cellular stress/apotosis Ceramide \\[nmol/L\\], higher levels represent more inflammation/apoptosis'}, {'measure': 'Blood markers (neutrotrophic factor, BDNF)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'brain-derived neurotrophic factor \\[ng/mL\\], higher levels represent more neuroplasticity'}, {'measure': 'Blood markers (hormonal)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Cortisol \\[µg/dL or nmol/L\\] and timepoint of blood test higher levels represent more stress response'}, {'measure': 'Blood markers (immunological markers)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'C-reactive protein (CRP) \\[mg/L\\], higher levels show systemic inflammation'}, {'measure': 'Saliva marker (cortisol)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'saliva cortisol (awakening and before bedtime), higher levels represent more stress response'}, {'measure': 'Saliva marker (α-amylase)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'saliva α-amylase activity \\[U/ml\\] (awakening and before bedtime), higher levels represent more stress response'}, {'measure': 'Stool markers', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'alpha-diversity'}, {'measure': 'Suicidality (clinician rated)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'measures in clinical interview (Montgomery-Åsberg Depression Rating Scale (MADRS)) (Item No. 10 out of 10 items, rated 0-6, higher values represent more suicidality)'}, {'measure': 'Suicidality (self-report)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': '9-Item Patient Health Questionnaire (PHQ-9) (Item No. 9 out of 9, rated 0-3 with higher scores indicating more suicidality)'}, {'measure': 'Response (depression)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4) to T1 (end of inpatient stay, normally 7 days up to 50 weeks).', 'description': '≥ 50% reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) score from T0 to T1 (10 Items, each item rated 0-6 points, minimum 0 points, maximum 60 points, higher scores indicate greater severity of depressive symptoms)'}, {'measure': 'Relapse (depression)', 'timeFrame': 'T1 (end of inpatient stay/discharge from clinic) to Follow-Up/T2 (three months after clinical discharge).', 'description': '≥ 10 points more from T1 to T2 in Montgomery-Åsberg Depression Rating Scale (MADRS) score or ≥ 22 points at T2 (10 Items, each item rated 0-6 points, minimum 0 points, maximum 60 points, higher scores indicate greater severity of depressive symptoms)'}, {'measure': 'Antidepressant medication', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'consideration of these classes of antidepressant drugs if these are given in a dosage that is effective as an antidepressant (e.g. for Mirtazapin not 7.5 mg, starting from 15 mg): SSRI/SNRI/NaSSA(Mirtazapin)/NDRI (Buproprion)/TZA/MAO-I/SARI (Trazodon)Agomelatin/other with classes of augmentation strategy: Lithium/antipsychotics/second antidepressant/other augmentation strategy sorted as: antidepressant monotherapy/antidepressant augmented therapy/other and change in therapy stategy (1. no; 2. yes drug substance (2.1) added/ (2.2) changed/ (2.3) removed; 3. yes dosage of antidepressant changed (3.1) increased/(3.2) decreased; 4. augmentation strategy changed)'}, {'measure': 'trait vs. state loneliness', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': "Given the absence of an established measure capable of differentiating between enduring (trait) and situational (state) loneliness, this aspect is captured by using a newly developed single item: 'In looking back upon my life, I would say that I have felt …'. Participants respond to this item on a four-point scale (1= mostly lonely throughout my life, 2= lonely from time to time, 3= only lonely at present, and 4= never lonely). Responses of 1 are intended to represent trait loneliness; options 2 and 3 represent state loneliness; and option 4 indicates no loneliness."}, {'measure': 'number of therapies participated', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4) to T1 (end of inpatient stay, normally 7 days up to 50 weeks).', 'description': 'frequency per week of psychotherapy, group interventions and other'}], 'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Montgomery-Åsberg Depression Rating Scale (MADRS) (10 Items, each item rated 0-6 points, minimum 0 points, maximum 60 points, higher scores indicate greater severity of depressive symptoms)'}, {'measure': 'Loneliness', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': '3 Item UCLA Loneliness Scale (3-Item UCLA) (3 items, each item rated 1-3 points, minimum 3 points, maximum 9 points, higher scores indicate greater loneliness)'}, {'measure': 'Depression', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Patient Health Questionnaire, 9-Item Depression Scale (PHQ-9) (9 Items, each item rated 0-4 points, minimum 0 points, maximum 27 points, higher scores indicate greater severity of depression)'}, {'measure': 'Loneliness', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': '6-Item short scales for Loneliness, De Jong Gierveld Loneliness Scale (6-Item DJGLS) (6 Items, each item rated 1-3 points, before the total score is calculated, the items are dichotomized, thus resulting in a sum score ranging from 0 to 6, wherein scores of 0-1 indicate no loneliness, 2-4 indicate moderate loneliness, and 5-6 indicate severe loneliness)'}], 'secondaryOutcomes': [{'measure': 'Social Support', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Fragebogen zur Sozialen Unterstützung (F-SoZ-U 14) (14 Item shortend form, each item rated 0-4 points, minimum 0 points, maximum 56 points, higher total scores indicating higher levels of perceived social support)'}, {'measure': 'Inpatient treatment duration', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4) to T1 (end of inpatient stay, normally 7 up to 50 weeks).', 'description': 'in days'}, {'measure': 'Quality of life in self-report', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'World Health Organization-Five Well-Being Index (WHO-5) (5 Items, each item rated 0-5 points, minimum 0 points, maximum 25 points, the total score (0-25) is transformed to a scale ranging from 0 to 100, with scores ≤50 indicating diminished well-being and higher scores representing higher well-beeing)'}, {'measure': 'Social Network measure (newly designed for this study)', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': "As there is no culture and language adapted version of a social network indice available an adapted and German-translated version is used to capture participants' social interaction partners during the prior two weeks. The questionnaire was newly developed, with item content informed by existing validated scales (Cohen Social Network Index (SNI), Lubben Social Network Scale (LSNS), Berkman - Social Network/Integration).\n\nVia the use of a yes/no response format, participants indicated whether they had personal or telephone contact with each of the following: (1) spouse or partner, (2) own children, (3) parents or parent-like figures, (4) other relatives (e.g., siblings, uncles, or aunts), (5) friends, (6) neighbors, (7) colleagues, (8) people known through voluntary activities, (9) in-laws (parents, sons, or daughters-in-law), and (10) members of their social group (e.g., community, congregation, sports, or music clubs).\n\nHigher total scores indicate greater social connectedness."}, {'measure': 'General health status', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Short Form 12 Health Survey (SF-12) (12 Items, Items rated 0-1, 1-3 and 1-5 and 1-6 scores represent eight dimensions of physical and mental well-beeing with two composite scores, items are recodet, z-transformed and normed, higher values indicate better health)'}, {'measure': 'Social Anxiety', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': 'Social Phobia Inventory (SPIN) (17 Items, each item rated 0-4 points, minimum 0 points, maximum 68 points, higher scores indicate greater severity of social anxiety, three subscales are available (fear 6 items, avoidance 7 items, physiological distress 4 items))'}, {'measure': 'Somatic Symptom Burden', 'timeFrame': 'Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2', 'description': '13-Item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-13) (13 Items, each item rated 0-2 points, minimum 0 points, maximum 34 points, higher values indicating more somatic symptoms)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['loneliness', 'depression', 'prospective', 'biosampling', 'clinical'], 'conditions': ['Depression Disorder', 'Loneliness']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective study is to better understand the link between loneliness and depression in the inpatient psychiatric treatment of depression. It aims to answer:\n\nDo lonely and not lonely persons benefit the same way from inpatient depression treatment? Is loneliness a clinical relevant factor in inpatient treatment of depression? What are the underlying biopsychosocial mechanisms?\n\nParticipants will be asked to do some\n\n* self-report questionnaires\n* clinical interview\n* biosampling (blood, saliva, stool) at three main measurement timepoints (1. begin of inpatient treatment, 2. day of discharge, 3. three months after discharge).', 'detailedDescription': "Loneliness and depression are widespread and severely debilitating health conditions. Notably, loneliness and depression are closely intertwined, with individuals suffering from depression being particularly vulnerable to loneliness. However, little is known regarding the clinical significance of loneliness in the treatment of depression and the biopsychosocial mechanisms underlying this association.\n\nTo examine the clinical relevance of the interplay between loneliness and depression, a prospective, noninterventional longitudinal design will be adopted. The study will be performed at the University Hospital and the community hospital in Erlangen, Germany. Every patient admitted to the hospital with depressive symptoms is eligible for screening according to the inclusion and exclusion criteria. Three main measurement points (T0, T1, and T2) and brief interim measurements conducted at two-week intervals (t0.1 to t0.X and t1.1-t1.6) will be utilized. After screening and clinical interviews, participants will complete the baseline measurements (T0). Thereafter, each participant will adhere to an individual period corresponding to the duration of that specific patient's inpatient stay at the clinic until the second measurement is obtained (T1). Follow-up will occur three months after T1.\n\nGiven that the effect sizes of the interaction between loneliness and depression in a clinical population are currently unknown, the sample size for this study was determined based on considerations of practicability and the population generalizability of the obtained results, as well as statistical plausibility.\n\nTo ensure the external validity of the results, it is important that both severely lonely depressive patients and less lonely depressive patients, as well as different disease trajectories and patient characteristics (e.g., age, sex, and number of comorbidities), can be identified. A sample size of approximately 200 participants is expected to ensure sufficient heterogeneity. This sample size is practically feasible due to the fact that, even when considering an inclusion rate of 50% and a dropout rate of 30% for the primary diagnosis of depression at the University Hospital and the community hospital in Erlangen, the recruitment potential clearly exceeds the target number of cases within an estimated period of two years.\n\nWithout the knowledge of which measured level of loneliness at baseline represents a strong level of loneliness and which measured level represents a weak level of loneliness in a depressed patient population, a median split of loneliness at baseline will be performed to calculate the statistical significance of the interaction between loneliness and depression in the inpatient and follow-up course (T0, T1, and T2). To detect a significant interaction effect of a mixed analysis of variance (ANOVA), when considering an α error of 0.05, a power of 0.9 (1-β error probability) and a correlation value among repeated measures of 0.5 for the groups defined as highly lonely and slightly lonely groups, the number of cases was calculated by using G\\*Power Version 3.1.9.7. Assuming a small effect size (f= 0.10), the desired sample size would be determined at n= 214 individuals; moreover, assuming a medium effect size (f= 0.25), the sample size would be n= 36 individuals. This indicates that there is statistical plausibility for detecting interaction effects between loneliness and depression with the target number of cases.\n\nEligibility screening and clinical diagnostic screening, along with interviews, are conducted by study physicians. Depression is assessed during a clinical interview (MADRS) by the patient's treatment team, which also determines when the patient will be discharged from the hospital. All of the self-report assessments are collected by the patients themselves by using the REDCap online survey application. Biosampling will be exclusively performed among participants recruited at the University Hospital to ensure methodologically consistent and rapid processing. Routine clinical data are primarily extracted from clinical documentation systems and consolidated prior to analysis (similar to other data sources).\n\nGiven that the study design does not permit definitive causal conclusions to be determined regarding the direction of effects, the findings are expected to provide valuable insights and relevant implications. In particular, the following insights can be obtained: (1) a report on whether more or less lonely patients receive equal benefits from inpatient multimodal depression treatment; (2) insights into changes in loneliness during and after depression treatment; (3) important findings regarding the shared and nonshared biopsychosocial mechanisms underlying loneliness and depression; and (4) the effects of loneliness and depression with respect to secondary outcomes, including quality of life and suicidality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who are admitted for inpatient treatment at one of the two psychiatric clinics in Erlangen (university hospital, community hospital), Germany, either electively or as an emergency case, due to depressive symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary diagnosis of depression according to ICD-10 (F32 or F33), as diagnosed by a physician or clinical psychologist in conjunction with the M.I.N.I. Mini-International Neuropsychiatric Interview diagnostic tools\n* inpatient elective or emergency admission to one of the two psychiatric clinics; - age over 18 years\n* sufficient understanding of spoken and written German\n* informed voluntary consent\n\nExclusion Criteria:\n\n* a current lack of capacity to provide consent (e.g., pronounced psychotic symptoms, stuporous depressive syndrome, and thought constriction to suicidality)\n* previous participation in the study\n* pregnancy or breastfeeding\n* inpatient stay of less than 7 days, even if the patients initially met the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07333027', 'briefTitle': 'Lonely in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}, 'officialTitle': 'Effects of Loneliness in the Treatment of Depression', 'orgStudyIdInfo': {'id': '25-435-B'}}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Franziska Sonnauer, Dr. med.', 'role': 'CONTACT', 'email': 'einsamkeit-depression.ps@uk-erlangen.de', 'phone': '00499131-8534597'}, {'name': 'Franziska Sonnauer, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Johannes Kornhuber, Prof. Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Blasko, Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilka Scheer', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '91056', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Franca Laura Fries, Dr. med.', 'role': 'CONTACT', 'email': 'Franca.Fries@bezirkskliniken-mfr.de', 'phone': '004991317535353'}, {'name': 'Maksym Druzenko', 'role': 'CONTACT', 'email': 'Maksym.Druzenko@bezirkskliniken-mfr.de', 'phone': '004991317535353'}, {'name': 'Franca Laura Fries, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maksym Druzenko', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bezirkskliniken Mittelfranken, Clinic for Psychiatry, Addiction, Psychotherapie and Psychosomatic Medicine', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Franziska Sonnauer, Dr. med., M.Sc.', 'role': 'CONTACT', 'email': 'franziska.sonnauer@uk-erlangen.de', 'phone': '00499131-8534597'}, {'name': 'Franca Fries, Dr. med.', 'role': 'CONTACT', 'email': 'Franca.Fries@bezirkskliniken-mfr.de', 'phone': '004991317530'}], 'overallOfficials': [{'name': 'Franziska Sonnauer, Dr. med., M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich-Alexander Universität Erlangen-Nürnberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD used in the results publication No final desicion has been made as several partners are involved and feasibility and regulatory requirements are still under review.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bezirkskliniken Mittelfranken, Clinic for Psychiatry, Addiction, Psychotherapie and Psychosomatic Medicine, Am Europakanal, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Franziska Sonnauer, Principal Investigator', 'investigatorFullName': 'Franziska Sonnauer', 'investigatorAffiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}}}}