Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT02737033
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2016-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stop Signal Task', 'timeFrame': 'Baseline and 4 hours', 'description': 'Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo'}], 'secondaryOutcomes': [{'measure': 'Change in Wechsler Adult Intelligence Scale (WAIS) - Digit Span subtest', 'timeFrame': 'Baseline and 4 hours', 'description': 'Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'Adults', 'Treatment', 'Rhodiola'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '21948938', 'type': 'BACKGROUND', 'citation': 'Seixas M, Weiss M, Muller U. Systematic review of national and international guidelines on attention-deficit hyperactivity disorder. J Psychopharmacol. 2012 Jun;26(6):753-65. doi: 10.1177/0269881111412095. Epub 2011 Sep 24.'}, {'pmid': '19580697', 'type': 'BACKGROUND', 'citation': 'Meszaros A, Czobor P, Balint S, Komlosi S, Simon V, Bitter I. Pharmacotherapy of adult attention deficit hyperactivity disorder (ADHD): a meta-analysis. Int J Neuropsychopharmacol. 2009 Sep;12(8):1137-47. doi: 10.1017/S1461145709990198. Epub 2009 Jul 7.'}, {'pmid': '20579741', 'type': 'BACKGROUND', 'citation': 'Iovieno N, Dalton ED, Fava M, Mischoulon D. Second-tier natural antidepressants: review and critique. J Affect Disord. 2011 May;130(3):343-57. doi: 10.1016/j.jad.2010.06.010. Epub 2010 Jun 26.'}, {'pmid': '20378318', 'type': 'BACKGROUND', 'citation': 'Panossian A, Wikman G, Sarris J. Rosenroot (Rhodiola rosea): traditional use, chemical composition, pharmacology and clinical efficacy. Phytomedicine. 2010 Jun;17(7):481-93. doi: 10.1016/j.phymed.2010.02.002. Epub 2010 Apr 7.'}, {'pmid': '21036578', 'type': 'BACKGROUND', 'citation': 'Hung SK, Perry R, Ernst E. The effectiveness and efficacy of Rhodiola rosea L.: a systematic review of randomized clinical trials. Phytomedicine. 2011 Feb 15;18(4):235-44. doi: 10.1016/j.phymed.2010.08.014. Epub 2010 Oct 30.'}, {'pmid': '11081987', 'type': 'BACKGROUND', 'citation': 'Darbinyan V, Kteyan A, Panossian A, Gabrielian E, Wikman G, Wagner H. Rhodiola rosea in stress induced fatigue--a double blind cross-over study of a standardized extract SHR-5 with a repeated low-dose regimen on the mental performance of healthy physicians during night duty. Phytomedicine. 2000 Oct;7(5):365-71. doi: 10.1016/S0944-7113(00)80055-0.'}, {'pmid': '15256690', 'type': 'BACKGROUND', 'citation': 'De Bock K, Eijnde BO, Ramaekers M, Hespel P. Acute Rhodiola rosea intake can improve endurance exercise performance. Int J Sport Nutr Exerc Metab. 2004 Jun;14(3):298-307. doi: 10.1123/ijsnem.14.3.298.'}, {'pmid': '12725561', 'type': 'BACKGROUND', 'citation': "Shevtsov VA, Zholus BI, Shervarly VI, Vol'skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G. A randomized trial of two different doses of a SHR-5 Rhodiola rosea extract versus placebo and control of capacity for mental work. Phytomedicine. 2003 Mar;10(2-3):95-105. doi: 10.1078/094471103321659780."}, {'pmid': '10839209', 'type': 'BACKGROUND', 'citation': 'Spasov AA, Wikman GK, Mandrikov VB, Mironova IA, Neumoin VV. A double-blind, placebo-controlled pilot study of the stimulating and adaptogenic effect of Rhodiola rosea SHR-5 extract on the fatigue of students caused by stress during an examination period with a repeated low-dose regimen. Phytomedicine. 2000 Apr;7(2):85-9. doi: 10.1016/S0944-7113(00)80078-1.'}, {'pmid': '19016404', 'type': 'BACKGROUND', 'citation': 'Olsson EM, von Scheele B, Panossian AG. A randomised, double-blind, placebo-controlled, parallel-group study of the standardised extract shr-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue. Planta Med. 2009 Feb;75(2):105-12. doi: 10.1055/s-0028-1088346. Epub 2008 Nov 18.'}, {'pmid': '6232345', 'type': 'BACKGROUND', 'citation': 'Logan GD, Cowan WB, Davis KA. On the ability to inhibit simple and choice reaction time responses: a model and a method. J Exp Psychol Hum Percept Perform. 1984 Apr;10(2):276-91. doi: 10.1037//0096-1523.10.2.276.'}, {'pmid': '16275215', 'type': 'BACKGROUND', 'citation': 'Mackin RS, Horner MD. Relationship of the Wender Utah Rating Scale to objective measures of attention. Compr Psychiatry. 2005 Nov-Dec;46(6):468-71. doi: 10.1016/j.comppsych.2005.03.004.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of Rhodiola rosea in the attention of adults with Attention Deficit/Hyperactivity Disorder (ADHD). Half of participants will receive Rhodiola rosea 800mg, while the other half will receive 800mg of placebo.', 'detailedDescription': 'The evaluation of new therapies in adults with Attention Deficit/Hyperactivity Disorder (ADHD) may be clinically useful. Rhodiola rosea is an herbal medicine used for centuries in various medical conditions. Many randomized controlled trials have evaluated its usefulness in stress and fatigue. There were benefits in attention in some of these studies. Mild side effects and beneficial antioxidant properties make reasonable an assessment of its potential benefits in adults with ADHD. To our knowledge, Rhodiola rosea has never been studied in adults with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfillment of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) diagnostic criteria for ADHD in Adults\n* Intelligence Quotient (IQ) above 70\n* Eligibility to Rhodiola rosea\n\nExclusion Criteria:\n\n* clinical contraindication to Rhodiola rosea\n* any unstable chronic illness without proper treatment (hypertension, heart, kidney or liver disease, etc)\n* any significant neurological disease (delirium, dementia, epilepsy, AIDS, head trauma, multiple sclerosis, stroke, etc)\n* unstable psychiatric comorbidities requiring immediate treatment (risk of suicide, current Substance Use Disorder, etc.)\n* pregnant, nursing or absence of reliable contraception\n* current use of nicotine (\\<30 days)\n* use of anticoagulants\n* current use of any psychoactive drug (\\<30 days)\n* prior use of stimulants\n* current or lifetime psychosis\n* current or lifetime bipolar disorder'}, 'identificationModule': {'nctId': 'NCT02737033', 'briefTitle': 'Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '150426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rhodiola', 'description': 'Rhodiola rosea 800mg single dose', 'interventionNames': ['Drug: Rhodiola']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo 800mg single dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rhodiola', 'type': 'DRUG', 'otherNames': ['Rhodiola rosea'], 'description': 'Rhodiola rosea 800mg', 'armGroupLabels': ['Rhodiola']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo pill'], 'description': 'innocuous pill manufactured to mimic Rhodiola', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Eugenio H Grevet, PhD', 'role': 'CONTACT', 'email': 'ehgrevet@gmail.com', 'phone': '555199877602'}, {'name': 'Marcelo M Victor, PhD', 'role': 'CONTACT', 'email': 'mvictor@via-rs.net', 'phone': '55 51 99639500'}], 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Eugenio Grevet, PhD', 'role': 'CONTACT', 'email': 'ehgrevet@gmail.com', 'phone': '55 51 3359-8094'}], 'overallOfficials': [{'name': 'Eugenio Grevet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hosptital de Clínicas de Porto Alegre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}