Black Seed Oil in ADHD

NCT06542887 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: BHCL463
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Attention-Deficit/Hyperactivity Disorder is one of the most prevalent neuropsychiatric disorders affecting children with known persistence into adulthood in about 60% of patients. The mainstay treatment for ADHD is the pharmacological treatment involving stimulants (methylphenidate, amphetamines) and non-stimulants (atomoxetine, guanfacine, clonidine). Although these options have been found to be effective, these agents may not always be promising, as a proportion of patients may not respond or may not be able to tolerate their adverse events. Thus, increasing studies are exploring alternative therapies for ADHD, focusing on the neuroprotective effects of dietary and natural compounds like antioxidants that can be serving as an alternative or supplement to classical treatment with fewer side effects. Oxidative stress and neuroinflammation have been extensively addressed in ADHD and several studies on antioxidants in pediatrics with ADHD have shown promising results in improving symptoms and reducing scores on ADHD questionnaires. Black seed oil (BSO) has shown anti-inflammatory and antioxidant properties in several human studies. Also numerous in-vitro studies have shown that nigella sativa possesses neuroprotective effects that are attributed to its antioxidant and anti-inflammatory effects. Thymoquinone (TQ) possesses the majority of nigella sativa oil (NSO) therapeutic benefits with the ability to target the central nervous system owing to its low molecular weight and lipophilic nature. In rats, thymoquinone administration significantly improved cognition by enhancing cholinergic function, synaptic plasticity, and attenuating oxidative damage and neuroinflammation, as shown by increased SOD and TAC and reduced MDA, NO, TNF-α immunoreactivity, and AChE activities. Previous human studies suggested that nigella sativa can stabilize mood, reduce anxiety, and regulate cognition, attention, and memory. In a previous animal study on ADHD mice model, Nigella sativa oil showed a reduction in inattention and hyperactivity with lower glutamate levels, and also showed higher recognition memory, glutathione peroxidase levels, dopamine levels, and neuronal density compared to the ethanol group only.

Conditions

ADHD

Keywords

ADHD, Atomoxetine, Oxidative stress, Neuroinflammation, Antioxidants, Nigella sativa, Vanderbilt Assessment Scale, Quality of life, CHQ-PF28

Outcome Measures

Primary Outcomes (1)

• Serum Glutathione Perioxidase

  Blood samples will be withdrawn from each patient at baseline and after 12 weeks. Samples will be centrifuged, and the sera will be separated and stored at -80°C till analysis. Serum GPx will be measured using human GPx ELISA kit at baseline and after 12 weeks.

  3 months

Secondary Outcomes (2)

• NICHQ Vanderbilt Assessment Scale-PARENT Informant

  3 months

• Child Health Questionnaire Parent Form 28 item (CHQ-PF28)

  3 months

Study Arms (2)

Black Seed Oil Group

EXPERIMENTAL

Drug: Atomoxetine; Drug: Black Seed Oil Cap/Tab

Controlled Group

ACTIVE COMPARATOR

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

Participants will continue receiving their treatment with atomoxetine at a dose of 0.5-1.4 mg/kg/day

Black Seed Oil Group; Controlled Group

Black Seed Oil Cap/Tab DRUG

Participants will receive black seed oil in the form of soft gelatin capsule 450 mg at a dose of 40-80 mg/kg/day given in one to two divided doses after meals for 12 weeks.

Black Seed Oil Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 12 years old who can swallow capsules.
• Diagnosed with ADHD according to the DSM-V criteria
• Having a stable dose of atomoxetine for at least 12 weeks prior to the study.

You may not qualify if:

• If there is any alteration in the ADHD treatment plan or being incompliant.
• Having any other psychiatric or neurological disorder that may interfere with the study outcomes like Autism, Anxiety, Obsessive compulsive disorder.
• Having any known allergy or hypersensitivity to black seed oil or its components.
• Having bleeding disorders or taking blood thinners.
• Having diabetes or taking medications that affect blood sugar levels.
• Having renal or hepatic impairment

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neuroinflammatory Diseases

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Central Study Contacts

Salwa Amin Abd Elhamid, Lecturer of Pediatrics

CONTACT

01115536976; salwa_amin@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: Prospective Randomized Controlled Open labeled

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share