Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02737020
• Other study ID #: 150425
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: March 2021

Study information

• Verified date: May 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Eugenio Grevet, PhD
• Phone: 55 51 3359-8094
• Email: ehgrevet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Drug:
• Rhodiola
Rhodiola rosea 200mg pill up to four times a day
• Placebo
up to four times a day

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (19)

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. Review. — View 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. Review. — View Citation

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. — View 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. — View 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. — View Citation

Mészáros A, Czobor P, Bálint S, Komlósi 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. Review. — View Citation

Morin CM, Belleville G, Bélanger 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. — View Citation

Olsson EM, von Schéele 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. — View 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. Review. — View Citation

Seixas M, Weiss M, Müller 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. Review. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Wechsler Scale digit subtest (WAIS-III)		Change from baseline WAIS-III at 4 weeks
Other	Change in Stop Signal Task		Change from baseline Stop Signal Task at 4 weeks
Other	Change in Barkley Side Effect Rating Scale (SERS)	Including Rhodiola rosea side effects	Change from baseline SERS at 4 weeks
Other	Change in Insomnia Severity Index (ISI)		Change from baseline ISI at 4 weeks
Other	Change in Beck-II Depression Scale		Change from baseline Beck-II Depression Scale at 4 weeks
Other	Change in Beck Anxiety Scale		Change from baseline Beck Anxiety Scale at 4 weeks
Other	Change in Adult ADHD Quality of Life Questionnaire (AAQoL)		Change from baseline AAQoL at 4 weeks
Primary	Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults		Change from baseline SNAP-IV at 4 weeks
Secondary	Change in Adult Self-Report Scale (ASRS)		Change from baseline ASRS at 4 weeks