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Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02808104
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):
NLS Pharmaceutics

Brief Summary:
The purpose of this study is to determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: mazindol Phase 2

Detailed Description:
This study is an outpatient, randomized, double-blind, placebo-controlled trial in which adult subjects with ADHD will be randomized to either oral mazindol controlled release or placebo once daily. Subjects will be treated with study medication or placebo for 6 weeks with visits occurring weekly to measure efficacy and any adverse events with adjustment of medication dosing as necessary.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults With DSM-5 Attention Deficit Hyperactivity Disorder (ADHD)
Actual Study Start Date : August 2016
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : March 28, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mazindol Controlled Release
Mazindol controlled release taken once daily. Dosage starting at 1 mg increasing or decreasing in increments of 1 mg depending on efficacy and tolerability. Maximum dose during the study is 3 mg taken once daily.
Drug: mazindol
Placebo Comparator: Placebo
Matching placebo
Drug: mazindol

Primary Outcome Measures :
  1. ADHD Rating Scale [ Time Frame: weekly rating up to six weeks ]

Secondary Outcome Measures :
  1. Clinical Global Improvement Scale [ Time Frame: weekly rating up to six weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has a primary diagnosis of ADHD established by a comprehensive psychiatric evaluation based on DSM-5 criteria.
  • Subject is functioning at an appropriate level intellectually as judged by the investigator.
  • Subject has a minimum baseline score of 28 at screen and at baseline using the ADHD-RS-DSM5
  • Subject has a minimum score of 4 (moderate) on the CGI-S at screening.
  • Women of child-bearing potential must be non-pregnant, non-lactating, and agree to be on an acceptable method of contraception. Acceptable methods of contraception include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
  • In good general physical health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
  • Subject is fluent in written and spoken English and is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
  • Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.

Exclusion Criteria:

  • Any primary DSM-5 Axis I disorder other than ADHD or any comorbid DSM-5 disorder that currently requires treatment.
  • Lifetime history of any DSM-5 bipolar disorder
  • Treatment with medications for any psychiatric or neurologic condition (e.g., amphetamines, MPH products, antidepressants, antipsychotics, mood stabilizers, anti-epileptics) or pressor agents concurrently or within 14 days of randomization.
  • Concurrent medical illness that would interfere with the conduct of the study in the opinion of the investigator.
  • History of significant cardiovascular disease, structural cardiac abnormality, cardiomyopathy, heart failure, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke, or other serious cardiac problems.
  • Family history of sudden cardiac death.
  • Clinically significant ECG abnormality or a QTc (Bazett correction) interval >450 msec.
  • Resting sitting systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg.
  • BMI <18 or >40 kg/m2.
  • Other medications that have CNS effects on cognition or attention (e.g., sedating antihistamines or decongestants).
  • Positive drug screen (UDS) at screening (with the exception of current ADHD medication).
  • Concomitant use of sensitive CYPA4/5 or CYP2D6 substrates with narrow therapeutic indices.
  • Pregnant or lactating.
  • Ongoing psychotherapeutic treatment for the treatment of ADHD begun less than three months before entry into this study.
  • Recent or current DSM-5 Substance Use Disorder of moderate or greater severity (i.e., > 4 SUD symptoms), excluding nicotine.
  • Suicidal ideation within past 3 months, suicidal behavior within the past year, or a C-SSRS score of 3, 4 or 5 on ideation item.
  • Evidence of any out-of-range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Study Investigator.
  • A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis), or any known/suspected hypersensitivity to any form of mazindol.
  • Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Study Investigator, would make the subject unsuitable for the study or put them at additional risk.
  • Treatment with an investigational drug within 30 days preceding the first dose of study medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808104

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United States, California
AVIDA Clinic
Newport Beach, California, United States, 92660
United States, Florida
CNS Healthcare
Jacksonville, Florida, United States, 32256
United States, Massachusetts
South Shore Psychiatric Services
Marshfield, Massachusetts, United States, 02050
United States, Michigan
Rochester Center for Behavorial Medicine
Rochester Hills, Michigan, United States, 48307
United States, Missouri
Midwest Research Group / St. Charles Psychiatric Associates
St. Charles, Missouri, United States, 63304
United States, Tennessee
Clinical Neuroscience Solutions
Memphis, Tennessee, United States, 38119
United States, Texas
Memorial Park Psychiatry / Bayou City Research
Houston, Texas, United States, 77007
Sponsors and Collaborators
NLS Pharmaceutics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NLS Pharmaceutics
ClinicalTrials.gov Identifier: NCT02808104    
Other Study ID Numbers: NLS-1001
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Dopamine Uptake Inhibitors
Dopamine Agents