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Trial record 2 of 237639 for:    ALL

Melatonin as Adjuvant Treatment for ADHD in Adults

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by Hospital Israelita Albert Einstein
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT03062839
First received: February 20, 2017
Last updated: NA
Last verified: February 2017
History: No changes posted
  Purpose
This study aims to evaluate the effect of melatonin supplementation as adjuvant treatment in ADHD in adults.

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Melatonin 5 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Melatonin as Adjuvant Treatment for ADHD in Adults

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • Adult ADHD Investigator Symptom Rating Scale. [ Time Frame: 12 weeks ]
    Each of the individual DSM-IV symptoms of ADHD is rated 0 to 3 on a scale of severity.


Secondary Outcome Measures:
  • Anxiety [ Time Frame: 12 weeks ]
    GAD-7 scale

  • Depression [ Time Frame: 12 weeks ]
    PHQ-9 scale

  • CGI-S / I [ Time Frame: 12 weeks ]
    Clinical Global Impression Severity / Improvement

  • Adverse Event Monitoring [ Time Frame: 12 weeks ]
    Adverse Event Monitoring


Estimated Enrollment: 120
Anticipated Study Start Date: March 1, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
Melatonin 5 mg taken 30 minutes before bed time
Drug: Melatonin 5 mg
Melatonin 5 mg taken 30 minutes before bed time
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03062839

Contacts
Contact: Mario FP Peres, MD 2151-0110

Locations
Brazil
Hospital Albert Einstein
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
  More Information

Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03062839     History of Changes
Other Study ID Numbers: TDAHMEL 
Study First Received: February 20, 2017
Last Updated: February 20, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 23, 2017