Melatonin as Adjuvant Treatment for ADHD in Adults

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

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Melatonin 5 mg

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mario FP Peres, MD; Phone Number: 2151-0110; Email: mariop3r3s@gmail.com
• Study Contact Backup: Name: Mario FP Peres, MD; Phone Number: 32855726; Email: mariop3r3s@gmail.com

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil
      • Recruiting
      • Hospital Albert Einstein
      • Contact: Mario F Peres, MD; Phone Number: 2151-0110; Email: mariop3r3s@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin; Melatonin 5 mg taken 30 minutes before bed time	Drug: Melatonin 5 mg; Melatonin 5 mg taken 30 minutes before bed time; Other Names: Melatonina
Placebo Comparator: Placebo; Placebo identical to melatonin capsule taken 30 min before bed time	Drug: Melatonin 5 mg; Melatonin 5 mg taken 30 minutes before bed time; Other Names: Melatonina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	GAD-7 scale	12 weeks
Depression	PHQ-9 scale	12 weeks
CGI-S / I	Clinical Global Impression Severity / Improvement	12 weeks
Adverse Event Monitoring	Adverse Event Monitoring	12 weeks

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: University of Sao Paulo; Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: TDAHMEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No