Attention Deficit Disorder With HyperactivityNCT03849807
Chiropractic Care on Behavior, Neurological Function and Quality of Life in ADHD Children - A Pilot Study
A study testing Experimental group in people with Attention Deficit Disorder With Hyperactivity, run by Riphah International University at 1 site in Pakistan.
Trial summary
To date the effects of chiropractic care on behavior and neurological function in children diagnosed with ADHD has not been investigated thoroughly and is limited mostly to case studies and retrospective case reviews. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Feb 2019to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- have been previously diagnosed with Attention Deficit Hypersensitivity Disorder based on the criteria outlined in the DSM-V.
Who cannot join
- have absolute contraindications to chiropractic adjustments
- have experienced previous significant adverse reactions to chiropractic care or manual therapies.
- investigators are unable to get consent from parents and caregivers of participating children in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Chiropractic Care on Behavior, Neurological Function and Quality of Life in Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Pilot Study
To date the effects of chiropractic care on behavior and neurological function in children diagnosed with ADHD has not been investigated thoroughly and is limited mostly to case studies and retrospective case reviews. Our research group recently completed a pilot study that investigated the effects of a single session of chiropractic care on oculomotor function and reading ability in children with ADHD. The findings of this study suggested that chiropractic care may have a role in improving oculomotor control and reading ability in this population group. This proposed study is the next step in this program of research and is a pilot clinical trial that will investigate whether 4 weeks of chiropractic care influences behavior, neurological function, or quality of life in children with ADHD.
Read the detailed description
ADHD is a disorder that may affect an individual's academic performance, social interactions, and interpersonal relationships amongst others. It is characterized by impulsiveness, hyperactivity, and inattention. It was previously thought that children overcome ADHD as they grow up, however, recent studies suggest that 30-60% of affected individuals continue to show significant symptoms of the disorder as adults and have associated difficulties such as lower educational and employment achievement. Conventional therapeutic approaches that are used with individuals with ADHD generally involve pharmaceutical interventions and behavioral therapies such as counseling and behavioral modification. However, little is known about the long term effectiveness of these treatment approaches which are also known to involve significant risks and complications.
ADHD is a neurodevelopmental disorder that is associated with significant alterations in brain development and function. These include changes in fronto-striatal pathways that can lead to difficulties with "top-down" control. It is also likely that connections in the parietal lobe and cerebellum are involved. These neurological changes are associated with a number of alterations to sensory filtering, sensorimotor gating, and sensorimotor control. This lends itself to a potential role for chiropractors in caring for children with ADHD because chiropractic care has been shown to alter a number of aspects of sensorimotor function.
Chiropractic is based on the theory that spinal adjustments applied to areas of spinal dysfunction, known as vertebral subluxations, can improve the function of the nervous system. Our research group has been testing this theory for the last 15 years. We have hypothesized that the articular dysfunction component of the vertebral subluxation results in altered afferent input to the central nervous system (CNS) that modifies the way in which the CNS processes and integrates all subsequent sensory input. This processing (i.e. sensorimotor integration), is a CNS function that appears most vulnerable to altered inputs. Recent studies have shown that chiropractic care alters sensorimotor filtering, cortical and cerebellar motor processing, and multisensory processing, all of which may be important in the neurodevelopment of ADHD. Given the nature of the neurological changes associated with ADHD and the growing body of evidence that suggests that chiropractic care may influence neurological function, it is possible that chiropractors may play a role in enhancing the neurological function of individuals with ADHD.
- Being tested
- Experimental group, Control group
- Keywords
- Attention Deficit Disorder with Hyperactivity, Children, Chiropractic, Neurological function, Quality of life
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).
Control groupOther
Participants in the group will receive usual health (Cognitive-Behavioral, psychosocial Therapy) care or wish to engage in during the course of the study as well as receiving a passive movement control intervention delivered by a chiropractor 3 times per week in the same hospital setting as the group receiving chiropractic care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Chiropractic care Receives: Other: Experimental group |
| Control group | Active comparator | Usual health care Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vanderbilt Attention Deficit Hyperactivity Disorder (ADHD) Diagnostic Rating Scale
Changes From Baseline, The Vanderbilt ADHD Diagnostic Rating Scale (VADRS) is a psychological assessment tool for Attention Deficit Hyperactivity Disorder (ADHD) symptoms and their effects on behavior and academic performance in children. It have two components: symptom assessment and impairment in performance. To meet criteria for ADHD diagnoses, one must have 6 positive responses to either the core 9 inattentive symptoms or core 9 hyperactive symptoms, or both. the respondent to rate the frequency of a child's behaviors on a 0-3 scale as follows: 0: "never"; 1: "occasionally"; 2: "often"; 3: "very often".
to rate the child's performance in school and his or her interactions with others on a 1-5 scale, with 1-2 meaning "above average", 3 meaning "average", and 4-5 meaning "problematic". To meet criteria for ADHD, there must be at least one score for the performance set that is either a 4 or 5, as these scores indicate impairment in performance.
Measured: baseline,4th week, 8th week
Swanson, Nolan and Pelham (SNAP) Questionnaire
Changes from the Baseline The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.
Measured: baseline,4th week, 8th week
ADHA Attention Deficit Hyperactivity Disorder Rating Scale IV (Home version)
Changes from the Baseline, The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). For inattention (IA) subscale raw score: Add the odd-numbered items
For hyperactivity-impulsivity (HI) subscale raw score: Add the even-numbered items. To obtain the total raw score: Add the IA and Hi subscale raw scores
Measured: baseline,4th week, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start2 Feb 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849807
- Sponsor's protocol ID
- RiphahIU Imran khan Niazi2
- Status last verified
- Jul 2022
- First submitted
- 20 Feb 2019
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harpin VA. The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i2-7. doi: 10.1136/adc.2004.059006.
PubMed 15665153Munoz DP, Armstrong IT, Hampton KA, Moore KD. Altered control of visual fixation and saccadic eye movements in attention-deficit hyperactivity disorder. J Neurophysiol. 2003 Jul;90(1):503-14. doi: 10.1152/jn.00192.2003. Epub 2003 Apr 2.
PubMed 12672781Sable JJ, Kyle MR, Knopf KL, Schully LT, Brooks MM, Parry KH, Diamond RE, Flink LA, Stowe R, Suna E, Thompson IA. The Sensory Gating Inventory as a potential diagnostic tool for attention-deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2012 Sep;4(3):141-4. doi: 10.1007/s12402-012-0079-1. Epub 2012 May 27.
PubMed 22644992Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6.
PubMed 22483612Henderson CN. The basis for spinal manipulation: chiropractic perspective of indications and theory. J Electromyogr Kinesiol. 2012 Oct;22(5):632-42. doi: 10.1016/j.jelekin.2012.03.008. Epub 2012 Apr 17.
PubMed 22513367Daligadu J, Haavik H, Yielder PC, Baarbe J, Murphy B. Alterations in cortical and cerebellar motor processing in subclinical neck pain patients following spinal manipulation. J Manipulative Physiol Ther. 2013 Oct;36(8):527-37. doi: 10.1016/j.jmpt.2013.08.003. Epub 2013 Sep 12.
PubMed 24035521Holt KR, Haavik H, Lee AC, Murphy B, Elley CR. Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated With Falls Risk in Older People: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2016 May;39(4):267-78. doi: 10.1016/j.jmpt.2016.02.003. Epub 2016 Apr 2.
PubMed 27050038Karpouzis F, Bonello R, Pollard H. Chiropractic care for paediatric and adolescent Attention-Deficit/Hyperactivity Disorder: A systematic review. Chiropr Osteopat. 2010 Jun 2;18:13. doi: 10.1186/1746-1340-18-13.
PubMed 20525195Rabe-Jablonska J. [Affective disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association -- diagnostic and statistical manual of mental disorders]. Psychiatr Pol. 1993 May-Jun;27(3):269-79. No abstract available. Polish.
PubMed 8356173McGough JJ, Loo SK, Sturm A, Cowen J, Leuchter AF, Cook IA. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015 Mar-Apr;8(2):299-304. doi: 10.1016/j.brs.2014.11.013. Epub 2014 Nov 28.
PubMed 25533244Conners CK. Rating scales in attention-deficit/hyperactivity disorder: use in assessment and treatment monitoring. J Clin Psychiatry. 1998;59 Suppl 7:24-30.
PubMed 9680050Childress AC, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Findling RL. Participant-perceived quality of life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):210-7. doi: 10.1089/cap.2013.0077. Epub 2014 May 9.
PubMed 24815910Rosner AL. Evidence-based medicine: revisiting the pyramid of priorities. J Bodyw Mov Ther. 2012 Jan;16(1):42-9. doi: 10.1016/j.jbmt.2011.05.003. Epub 2011 Jun 24.
PubMed 22196426Hancock MJ, Maher CG, Latimer J, McAuley JH. Selecting an appropriate placebo for a trial of spinal manipulative therapy. Aust J Physiother. 2006;52(2):135-8. doi: 10.1016/s0004-9514(06)70049-6.
PubMed 16764551
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chiropractic Care on Behavior, Neurological Function and Quality of Life in Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03849807
- Acronym / sponsor ID
- RiphahIU Imran khan Niazi2
- Keywords
- Attention Deficit Disorder with Hyperactivity, Children, Chiropractic, Neurological function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date the effects of chiropractic care on behavior and neurological function in children diagnosed with ADHD has not been investigated thoroughly and is limited mostly to case studies and retrospective case reviews. Our research group recently completed a pilot study that investigated the effects of a single session of chiropractic care on oculomotor function and reading ability in children with ADHD. The findings of this study suggested that chiropractic care may have a role in improving oculomotor control and reading ability in this population group. This proposed study is the next step in this program of research and is a pilot clinical trial that will investigate whether 4 weeks of chiropractic care influences behavior, neurological function, or quality of life in children with ADHD.
Detailed description
ADHD is a disorder that may affect an individual's academic performance, social interactions, and interpersonal relationships amongst others. It is characterized by impulsiveness, hyperactivity, and inattention. It was previously thought that children overcome ADHD as they grow up, however, recent studies suggest that 30-60% of affected individuals continue to show significant symptoms of the disorder as adults and have associated difficulties such as lower educational and employment achievement. Conventional therapeutic approaches that are used with individuals with ADHD generally involve pharmaceutical interventions and behavioral therapies such as counseling and behavioral modification. However, little is known about the long term effectiveness of these treatment approaches which are also known to involve significant risks and complications.
ADHD is a neurodevelopmental disorder that is associated with significant alterations in brain development and function. These include changes in fronto-striatal pathways that can lead to difficulties with "top-down" control. It is also likely that connections in the parietal lobe and cerebellum are involved. These neurological changes are associated with a number of alterations to sensory filtering, sensorimotor gating, and sensorimotor control. This lends itself to a potential role for chiropractors in caring for children with ADHD because chiropractic care has been shown to alter a number of aspects of sensorimotor function.
Chiropractic is based on the theory that spinal adjustments applied to areas of spinal dysfunction, known as vertebral subluxations, can improve the function of the nervous system. Our research group has been testing this theory for the last 15 years. We have hypothesized that the articular dysfunction component of the vertebral subluxation results in altered afferent input to the central nervous system (CNS) that modifies the way in which the CNS processes and integrates all subsequent sensory input. This processing (i.e. sensorimotor integration), is a CNS function that appears most vulnerable to altered inputs. Recent studies have shown that chiropractic care alters sensorimotor filtering, cortical and cerebellar motor processing, and multisensory processing, all of which may be important in the neurodevelopment of ADHD. Given the nature of the neurological changes associated with ADHD and the growing body of evidence that suggests that chiropractic care may influence neurological function, it is possible that chiropractors may play a role in enhancing the neurological function of individuals with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupChiropractic care |
| Control group | Active comparator | Other: Control groupUsual health care |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- have been previously diagnosed with Attention Deficit Hypersensitivity Disorder based on the criteria outlined in the DSM-V.
Key exclusion criteria (3 listed)
- have absolute contraindications to chiropractic adjustments
- have experienced previous significant adverse reactions to chiropractic care or manual therapies.
- investigators are unable to get consent from parents and caregivers of participating children in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupthe intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy). | Other | Experimental group |
| Control groupParticipants in the group will receive usual health (Cognitive-Behavioral, psychosocial Therapy) care or wish to engage in during the course of the study as well as receiving a passive movement control intervention delivered by a chiropractor 3 times per week in the same hospital setting as the group receiving chiropractic care. | Other | Control group |
Primary outcome
Vanderbilt Attention Deficit Hyperactivity Disorder (ADHD) Diagnostic Rating Scale
Time frame: baseline,4th week, 8th week
Changes From Baseline, The Vanderbilt ADHD Diagnostic Rating Scale (VADRS) is a psychological assessment tool for Attention Deficit Hyperactivity Disorder (ADHD) symptoms and their effects on behavior and academic performance in children. It have two components: symptom assessment and impairment in performance. To meet criteria for ADHD diagnoses, one must have 6 positive responses to either the core 9 inattentive symptoms or core 9 hyperactive symptoms, or both. the respondent to rate the frequency of a child's behaviors on a 0-3 scale as follows: 0: "never"; 1: "occasionally"; 2: "often"; 3: "very often". to rate the child's performance in school and his or her interactions with others on a 1-5 scale, with 1-2 meaning "above average", 3 meaning "average", and 4-5 meaning "problematic". To meet criteria for ADHD, there must be at least one score for the performance set that is either a 4 or 5, as these scores indicate impairment in performance.
Swanson, Nolan and Pelham (SNAP) Questionnaire
Time frame: baseline,4th week, 8th week
Changes from the Baseline The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.
ADHA Attention Deficit Hyperactivity Disorder Rating Scale IV (Home version)
Time frame: baseline,4th week, 8th week
Changes from the Baseline, The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). For inattention (IA) subscale raw score: Add the odd-numbered items For hyperactivity-impulsivity (HI) subscale raw score: Add the even-numbered items. To obtain the total raw score: Add the IA and Hi subscale raw scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 15665153Harpin VA. The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i2-7. doi: 10.1136/adc.2004.059006.
- Background: PubMed 12672781Munoz DP, Armstrong IT, Hampton KA, Moore KD. Altered control of visual fixation and saccadic eye movements in attention-deficit hyperactivity disorder. J Neurophysiol. 2003 Jul;90(1):503-14. doi: 10.1152/jn.00192.2003. Epub 2003 Apr 2.
- Background: PubMed 22644992Sable JJ, Kyle MR, Knopf KL, Schully LT, Brooks MM, Parry KH, Diamond RE, Flink LA, Stowe R, Suna E, Thompson IA. The Sensory Gating Inventory as a potential diagnostic tool for attention-deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2012 Sep;4(3):141-4. doi: 10.1007/s12402-012-0079-1. Epub 2012 May 27.
- Background: PubMed 22483612Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6.
- Background: PubMed 22513367Henderson CN. The basis for spinal manipulation: chiropractic perspective of indications and theory. J Electromyogr Kinesiol. 2012 Oct;22(5):632-42. doi: 10.1016/j.jelekin.2012.03.008. Epub 2012 Apr 17.
- Background: PubMed 24035521Daligadu J, Haavik H, Yielder PC, Baarbe J, Murphy B. Alterations in cortical and cerebellar motor processing in subclinical neck pain patients following spinal manipulation. J Manipulative Physiol Ther. 2013 Oct;36(8):527-37. doi: 10.1016/j.jmpt.2013.08.003. Epub 2013 Sep 12.
- Background: PubMed 27050038Holt KR, Haavik H, Lee AC, Murphy B, Elley CR. Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated With Falls Risk in Older People: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2016 May;39(4):267-78. doi: 10.1016/j.jmpt.2016.02.003. Epub 2016 Apr 2.
- Background: PubMed 20525195Karpouzis F, Bonello R, Pollard H. Chiropractic care for paediatric and adolescent Attention-Deficit/Hyperactivity Disorder: A systematic review. Chiropr Osteopat. 2010 Jun 2;18:13. doi: 10.1186/1746-1340-18-13.
- Background: PubMed 8356173Rabe-Jablonska J. [Affective disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association -- diagnostic and statistical manual of mental disorders]. Psychiatr Pol. 1993 May-Jun;27(3):269-79. No abstract available. Polish.
- Background: PubMed 25533244McGough JJ, Loo SK, Sturm A, Cowen J, Leuchter AF, Cook IA. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015 Mar-Apr;8(2):299-304. doi: 10.1016/j.brs.2014.11.013. Epub 2014 Nov 28.
- Background: PubMed 9680050Conners CK. Rating scales in attention-deficit/hyperactivity disorder: use in assessment and treatment monitoring. J Clin Psychiatry. 1998;59 Suppl 7:24-30.
- Background: PubMed 24815910Childress AC, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Findling RL. Participant-perceived quality of life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):210-7. doi: 10.1089/cap.2013.0077. Epub 2014 May 9.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Attention Deficit Disorder With Hyperactivity, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vanderbilt Attention Deficit Hyperactivity Disorder (ADHD) Diagnostic Rating Scale (time frame: baseline,4th week, 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849807, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.