Melatonin as Adjuvant Treatment for ADHD in Adults

NCT03062839 | Unknown Phase 3 DMC

• 1 other identifier: TDAHMEL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of melatonin supplementation as adjuvant treatment in ADHD in adults.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Adult ADHD Investigator Symptom Rating Scale.

  Each of the individual DSM-IV symptoms of ADHD is rated 0 to 3 on a scale of severity.

  12 weeks

Secondary Outcomes (4)

• Anxiety

  12 weeks

• Depression

  12 weeks

• CGI-S / I

  12 weeks

• Adverse Event Monitoring

  12 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin 5 mg taken 30 minutes before bed time

Drug: Melatonin 5 mg

Placebo

PLACEBO COMPARATOR

Placebo identical to melatonin capsule taken 30 min before bed time

Drug: Melatonin 5 mg

Interventions

Melatonin 5 mg DRUG

Melatonin 5 mg taken 30 minutes before bed time

Also known as: Melatonina

Melatonin; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female age 18-60 inclusive. Primary diagnosis of ADHD AISRS total score ≥ 24 CGI-S ≥4 (moderately ill or worse). Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
• Has given written informed consent to participate in the study.

You may not qualify if:

• BMI less than18.5 or greater than 35. Any underlying/ history or current diagnosis of systemic and/or metabolic disease (e.g. diabetes, Crohn's disease) and/or neurological condition state that may render the subject illegible to participate in the study as assessed by medical history, physical exam, clinical and lab evaluation.
• History of uncontrolled hypertension or a resting systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg (Subjects with well controlled hypertension on a stable dose (2 months) of anti-hypertensives will be allowed to participate).
• Major depression or anxiety disorder which is a focus of treatment or requires taking medication.
• A lifetime history of psychosis or bipolar disorder Has any concurrent chronic or unstable medical condition that could confound with the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
• Subjects taking any medication with CNS effects Subjects with a history of two or more prior failed adequate trials of ADHD treatment due to adverse events.
• Use of dietary supplements with potential CNS effect, including omega-3 supplements, 30 days before study initiation and throughout the study.
• Clinical history of cognitive impairment in judgment of investigator. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to randomization. Women of childbearing potential must agree to use adequate birth control for the entire duration of the study.
• Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug abuse or dependence (excluding nicotine).
• Has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
• Previous use of melatonin or melatonin analogues

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital Albert Einstein

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mario FP Peres, MD

CONTACT

2151-0110; mariop3r3s@gmail.com

Mario FP Peres, MD

CONTACT

32855726; mariop3r3s@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: June 30, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)