Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-03-31 @ 5:03 AM
Study NCT ID:
NCT00748956
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2008-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009478', 'term': 'Neuropeptide Y'}], 'ancestors': [{'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adriana.feder@mssm.edu', 'phone': '212-659-9145', 'title': 'Dr. Adriana Feder', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small sample size'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Headache and Nausea', 'notes': 'ER evaluation for headache and nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'notes': 'Headache requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Levels of NPY in CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'OG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '329.4', 'spread': '119.9', 'groupId': 'OG001'}, {'value': '351.0', 'spread': '41.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'on study day 2', 'description': 'Levels of Neuropeptide Y in the cerebrospinal fluid', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systematic Assessment of Treatment-Emergent Effects (SAFTEE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'OG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'on study day 2', 'description': 'Number of participants with serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Appetite Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'OG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'timeFrame': 'on study day 2', 'description': 'measure in 2 hours post intranasal administration', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected'}, {'type': 'SECONDARY', 'title': 'Post-sleep Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'OG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'timeFrame': 'on study day 2', 'description': 'measure in the morning', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptoms (QIDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'OG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'timeFrame': 'on study day 2', 'description': 'measure in 2 hours post intranasal administration', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected'}, {'type': 'SECONDARY', 'title': 'Profile of Mood States (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'OG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'timeFrame': 'on study day 2', 'description': 'measure in 2 hours post intranasal administration and on the next morning', 'reportingStatus': 'POSTED', 'populationDescription': 'data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'FG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY\n\nLow dose NPY: 50nmol, administered intranasally'}, {'id': 'BG001', 'title': 'High Dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY\n\nHigh dose NPY: 100nmol administered intranasally'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo comparator\n\nPlacebo: placebo comparator (0nmol)) administered intranasally'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-03', 'studyFirstSubmitDate': '2008-09-08', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2008-09-08', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-12', 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of NPY in CSF', 'timeFrame': 'on study day 2', 'description': 'Levels of Neuropeptide Y in the cerebrospinal fluid'}], 'secondaryOutcomes': [{'measure': 'Systematic Assessment of Treatment-Emergent Effects (SAFTEE)', 'timeFrame': 'on study day 2', 'description': 'Number of participants with serious adverse events'}, {'measure': 'Appetite Scale', 'timeFrame': 'on study day 2', 'description': 'measure in 2 hours post intranasal administration'}, {'measure': 'Post-sleep Questionnaire', 'timeFrame': 'on study day 2', 'description': 'measure in the morning'}, {'measure': 'Quick Inventory of Depressive Symptoms (QIDS)', 'timeFrame': 'on study day 2', 'description': 'measure in 2 hours post intranasal administration'}, {'measure': 'Profile of Mood States (POMS)', 'timeFrame': 'on study day 2', 'description': 'measure in 2 hours post intranasal administration and on the next morning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mood Disorder', 'Anxiety Disorders'], 'conditions': ['Mood Disorder', 'Anxiety Disorders']}, 'referencesModule': {'references': [{'pmid': '14625151', 'type': 'BACKGROUND', 'citation': 'Morgan CA 3rd, Rasmusson AM, Winters B, Hauger RL, Morgan J, Hazlett G, Southwick S. Trauma exposure rather than posttraumatic stress disorder is associated with reduced baseline plasma neuropeptide-Y levels. Biol Psychiatry. 2003 Nov 15;54(10):1087-91. doi: 10.1016/s0006-3223(03)00433-5.'}, {'pmid': '10807963', 'type': 'BACKGROUND', 'citation': 'Morgan CA 3rd, Wang S, Southwick SM, Rasmusson A, Hazlett G, Hauger RL, Charney DS. Plasma neuropeptide-Y concentrations in humans exposed to military survival training. Biol Psychiatry. 2000 May 15;47(10):902-9. doi: 10.1016/s0006-3223(99)00239-5.'}, {'pmid': '10715359', 'type': 'BACKGROUND', 'citation': 'Rasmusson AM, Hauger RL, Morgan CA, Bremner JD, Charney DS, Southwick SM. Low baseline and yohimbine-stimulated plasma neuropeptide Y (NPY) levels in combat-related PTSD. Biol Psychiatry. 2000 Mar 15;47(6):526-39. doi: 10.1016/s0006-3223(99)00185-7.'}, {'pmid': '9608581', 'type': 'BACKGROUND', 'citation': 'Rasmusson AM, Southwick SM, Hauger RL, Charney DS. Plasma neuropeptide Y (NPY) increases in humans in response to the alpha 2 antagonist yohimbine. Neuropsychopharmacology. 1998 Jul;19(1):95-8. doi: 10.1016/S0893-133X(97)00199-1.'}, {'pmid': '10549813', 'type': 'BACKGROUND', 'citation': 'Thorsell A, Carlsson K, Ekman R, Heilig M. Behavioral and endocrine adaptation, and up-regulation of NPY expression in rat amygdala following repeated restraint stress. Neuroreport. 1999 Sep 29;10(14):3003-7. doi: 10.1097/00001756-199909290-00024.'}, {'pmid': '2611661', 'type': 'BACKGROUND', 'citation': 'Flood JF, Baker ML, Hernandez EN, Morley JE. Modulation of memory processing by neuropeptide Y varies with brain injection site. Brain Res. 1989 Nov 27;503(1):73-82. doi: 10.1016/0006-8993(89)91706-x.'}, {'pmid': '15337373', 'type': 'BACKGROUND', 'citation': 'Heilig M. The NPY system in stress, anxiety and depression. Neuropeptides. 2004 Aug;38(4):213-24. doi: 10.1016/j.npep.2004.05.002.'}, {'pmid': '17979774', 'type': 'BACKGROUND', 'citation': 'Eaton K, Sallee FR, Sah R. Relevance of neuropeptide Y (NPY) in psychiatry. Curr Top Med Chem. 2007;7(17):1645-59. doi: 10.2174/156802607782341037.'}, {'pmid': '15784158', 'type': 'BACKGROUND', 'citation': 'Nikisch G, Agren H, Eap CB, Czernik A, Baumann P, Mathe AA. Neuropeptide Y and corticotropin-releasing hormone in CSF mark response to antidepressive treatment with citalopram. Int J Neuropsychopharmacol. 2005 Sep;8(3):403-10. doi: 10.1017/S1461145705005158. Epub 2005 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'There is growing evidence that neuropeptides act as neuronal messengers in the brain and have diverse functions that may include the regulation of mood and behavior. For example, neuropeptide Y (NPY) is thought to play a role in the adaptive stress response. The therapeutic application of neuropeptides for psychiatric disorders has been limited by difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data suggest that intranasal administration may provide a means of effectively delivering some of these neuropeptides to the brain. Thus far it is unclear if this is the case for NPY. The aims of this project are:\n\n1. To evaluate, in 15 healthy male volunteers aged 25-45, the effect of intranasal NPY administration (0, 50 and 100 nmol) on its levels in cerebrospinal fluid (CSF), measured by means of lumbar puncture using an intraspinal catheter between L4 and L5, and in plasma, measured using an intravenous catheter in the forearm. One of the three treatments will be administered to each participant in a double-blind fashion. The 0 nmol condition will serve as the placebo control.\n2. To test the effect of intranasal NPY administration on mood and anxiety.', 'detailedDescription': 'There is growing evidence that neuropeptides, including neuropeptide Y (NPY), act as neuronal messengers in the brain and have diverse neurobehavioral functions. Their therapeutic application for psychiatric disorders has been limited, however, by difficult and unreliable penetration of the blood-brain barrier (BBB). The BBB has prevented the use of many therapeutic agents for treating central nervous system (CNS) disorders. Several molecules have successfully been administered through intranasal delivery, however, thanks to the unique connection that the nerves involved in sensing odors and chemicals provide between the CNS and its environment.\n\nNPY, the most abundant peptide in the mammalian brain, is co-localized with norepinephrine in sympathetic nerve fibers and has been of longstanding interest to our research group (Morgan et al., 2002; Morgan et al., 2003; Morgan et al., 2001; Morgan et al., 2000; Rasmusson et al., 2000; Rasmusson et al., 1998) because of its potential role in modulating mood and anxiety. NPY has been implicated as factor in the adaptive stress response (Thorsell et al., 1999), and has been shown to impact the consolidation of fear-related memories after shock (Flood et al., 1989). Clinically, lower plasma NPY levels have been correlated with greater psychological distress, increased symptoms of dissociation, and poorer performance among active duty military personnel. Acute stress in humans has been found to elicit NPY release, in a manner parallel to the changes in cortisol and norepinephrine that are usually seen, with a blunting of the plasma NPY response in response to yohimbine (Morgan et al., 2002). Baseline NPY levels in combat veterans with PTSD are reduced compared to healthy non-traumatized individuals (Rasmusson et al., 2000). Another study found that repeated exposure to traumatic stress, rather than the presence of PTSD or PTSD-type symptoms, is associated with a reduction in baseline plasma NPY (Morgan et al., 2003). A recent report found deceased CSF concentrations of NPY in patients with treatment resistant unipolar major depression (Heilig et al 2004). In summary, there has been suggestion from studies in patients with anxiety and mood disorders as well as healthy volunteers of an abnormal regulation of this peptide.\n\nIn this study, we will evaluate intranasal administration of NPY in healthy male volunteers ages 25-45 using a specialized delivery device. Pending the initial feasibility and tolerability in healthy volunteers, future protocols will examine the effect of intranasal NPY administration in patients with disorders such as PTSD, major depression, panic disorder, and social anxiety disorder.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 25-45.\n* No history of Axis I disorder as defined in the DSM-IV other than past nicotine abuse or dependence or adjustment disorder.\n\nExclusion Criteria:\n\n* Nicotine or caffeine abuse or dependence within the preceding 3 months.\n* History or complaint of nasal disorders or allergies.\n* Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic.\n* Significant obesity (BMI \\> 30), scoliosis, spinal stenosis or a history of lumbosacral laminectomy.\n* Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG.\n* Current use of any medications that have effects on CNS function.\n* Prior sinonasal surgery, or significant nasal polyps as determined by nasal endoscopy.'}, 'identificationModule': {'nctId': 'NCT00748956', 'acronym': 'NPY', 'briefTitle': 'Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'GCO 05-0986'}, 'secondaryIdInfos': [{'id': 'PT050986'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose NPY', 'description': 'Low dose, Receive 50 nmol dose of NPY', 'interventionNames': ['Drug: Low dose NPY']}, {'type': 'EXPERIMENTAL', 'label': 'High dose NPY', 'description': 'High Dose, Receive 100 nmol dose of NPY', 'interventionNames': ['Drug: High dose NPY']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Low dose NPY', 'type': 'DRUG', 'otherNames': ['Neuropeptide Y'], 'description': '50nmol, administered intranasally', 'armGroupLabels': ['Low dose NPY']}, {'name': 'High dose NPY', 'type': 'DRUG', 'otherNames': ['Neuropeptide Y'], 'description': '100nmol administered intranasally', 'armGroupLabels': ['High dose NPY']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo comparator (0nmol)) administered intranasally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Adriana Feder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Dennis Charney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dennis Charney', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dean', 'investigatorFullName': 'Dennis Charney', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}