Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

• ClinicalTrials.gov Identifier: NCT02737020
• Recruitment Status: Unknown
• First Posted: April 13, 2016
• Last Update Posted: May 29, 2019
• Sponsor: Hospital de Clinicas de Porto Alegre
• Information provided by (Responsible Party): Hospital de Clinicas de Porto Alegre

Tracking Information

• First Submitted Date: March 9, 2016
• First Posted Date: April 13, 2016
• Last Update Posted Date: May 29, 2019
• Actual Study Start Date: April 2016
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 7, 2016): Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults [ Time Frame: Change from baseline SNAP-IV at 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 7, 2016): Change in Adult Self-Report Scale (ASRS) [ Time Frame: Change from baseline ASRS at 4 weeks ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 7, 2016)

• Change in Wechsler Scale digit subtest (WAIS-III) [ Time Frame: Change from baseline WAIS-III at 4 weeks ]
• Change in Stop Signal Task [ Time Frame: Change from baseline Stop Signal Task at 4 weeks ]
• Change in Barkley Side Effect Rating Scale (SERS) [ Time Frame: Change from baseline SERS at 4 weeks ]
  Including Rhodiola rosea side effects
• Change in Insomnia Severity Index (ISI) [ Time Frame: Change from baseline ISI at 4 weeks ]
• Change in Beck-II Depression Scale [ Time Frame: Change from baseline Beck-II Depression Scale at 4 weeks ]
• Change in Beck Anxiety Scale [ Time Frame: Change from baseline Beck Anxiety Scale at 4 weeks ]
• Change in Adult ADHD Quality of Life Questionnaire (AAQoL) [ Time Frame: Change from baseline AAQoL at 4 weeks ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
• Official Title: Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
• Brief Summary: This study evaluates the use of Rhodiola rosea in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola rosea, while the other half will receive placebo.
• Detailed Description: 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 was never studied in ADHD.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Attention Deficit/Hyperactivity Disorder

Intervention

• Drug: Rhodiola
  Rhodiola rosea 200mg pill up to four times a day
  Other Name: Rhodiola rosea
• Drug: Placebo
  up to four times a day
  Other Name: pill manufactured to mimic Rhodiola rosea 200mg

Study Arms

• Experimental: Rhodiola
  Rhodiola rosea 200mg up to four times a day for 28 days
  Intervention: Drug: Rhodiola
• Placebo Comparator: Placebo
  Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days
  Intervention: Drug: Placebo

Publications *

• Swanson JM, Kraemer HC, Hinshaw SP, Arnold LE, Conners CK, Abikoff HB, Clevenger W, Davies M, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Jensen PS, March JS, Newcorn JH, Owens EB, Pelham WE, Schiller E, Severe JB, Simpson S, Vitiello B, Wells K, Wigal T, Wu M. Clinical relevance of the primary findings of the MTA: success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):168-79. doi: 10.1097/00004583-200102000-00011.
• Brod M, Johnston J, Able S, Swindle R. Validation of the adult attention-deficit/hyperactivity disorder quality-of-life Scale (AAQoL): a disease-specific quality-of-life measure. Qual Life Res. 2006 Feb;15(1):117-29. doi: 10.1007/s11136-005-8325-z.
• Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, Howes MJ, Jin R, Secnik K, Spencer T, Ustun TB, Walters EE. The World Health Organization Adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005 Feb;35(2):245-56. doi: 10.1017/s0033291704002892.
• 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.
• Sonuga-Barke EJ, Coghill D, Wigal T, DeBacker M, Swanson J. Adverse reactions to methylphenidate treatment for attention-deficit/hyperactivity disorder: structure and associations with clinical characteristics and symptom control. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):683-90. doi: 10.1089/cap.2009.0024.
• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
• Gomes-Oliveira MH, Gorenstein C, Lotufo Neto F, Andrade LH, Wang YP. Validation of the Brazilian Portuguese version of the Beck Depression Inventory-II in a community sample. Braz J Psychiatry. 2012 Dec;34(4):389-94. doi: 10.1016/j.rbp.2012.03.005.
• Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and the State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996 Apr;29(4):453-7.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 7, 2016): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2021
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Fulfillment of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) diagnostic criteria for ADHD in Adults
• Intelligence Quotient (IQ) above 70
• Eligibility to Rhodiola rosea

Exclusion Criteria:

• clinical contraindication fro Rhodiola rosea -
• any unstable chronic illness without proper treatment (hypertension, heart, kidney or liver disease)
• any significant neurological disease (delirium, dementia, epilepsy, AIDS, head trauma, multiple sclerosis, stroke, etc)
• unstable psychiatric comorbidities requiring immediate treatment (risk of suicide, current Substance Use Disorder, etc.)
• pregnant, nursing or absence of reliable contraception
• current use of nicotine (<30 days)
• use of anticoagulants
• current use of any psychoactive drug (<30 days)
• prior use of stimulants
• current or lifetime psychosis- current or lifetime bipolar disorder

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT02737020
• Other Study ID Numbers: 150425
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Hospital de Clinicas de Porto Alegre
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital de Clinicas de Porto Alegre
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eugenio Grevet, PhD; Hospital de Clínicas de Porto Alegre

• PRS Account: Hospital de Clinicas de Porto Alegre
• Verification Date: May 2019