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CompletedNCT01752296MAPUpdated Dec 4, 2013

Psychological Concomitants of Morquio Syndrome (The MAP Study)

An observational study in Morquio Disease and Mucopolysaccharidosis IV, sponsored by Nadia Ali, PhD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-04.

Sponsored by Nadia Ali, PhD · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years and older
Sex
All
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Study summary

Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal recessive genetic lysosomal storage disorder. Research thus far regarding lysosomal storage diseases (LSDs) in general, including Morquio, has primarily focused on exploring the causes of and finding a treatment for the physical aspects of the various diseases. Less attention has been paid to the psychological or emotional toll of these diseases, whether they are direct symptoms of the diseases themselves or reactions to living with a chronic progressive disease.

It is well established in the health psychology literature, however, that the interaction between our physical health and our psychological health is bidirectional; that is, just as our physical health affects us emotionally (e.g. chronic pain can contribute to depression), so can our psychological health affect us physically (e.g. anxiety can contribute to feelings of chest pain). It is thus critically important to pay attention to the emotional and psychological symptoms associated with all lysosomal storage diseases, including Morquio, and expand our treatment standard of care to include mental health treatment, if necessary.

The first step in understanding and treating psychological conditions in Morquio disease is determining the natural occurrence of psychological symptoms in this population in comparison with non-medical populations. As little has been done in this regard, a pilot study documenting the occurrence rate of psychological issues and overall quality of life in patients with Morquio is the first item in order and will be the focus of this study.

Approximately 20 patients with Morquio disease will be invited to participate, recruited through Emory's Lysosomal Storage Disease Center, as well as through attendance at Morquio support groups and relevant regional, national and/or international meetings. Once consented, patients will be asked to complete three different self-report questionnaires, including the Achenbach System of Empirically Based Assessment (ASEBA) Adult Self-Report (ASR) or Older Adult Self-Report (OASR) questionnaire, the Short Form 36-item Health Questionnaire (SF-36), and the Brief Pain Inventory (BPI). Group aggregate data only will be reported; individual questionnaire content and results will be held confidential, except as in accordance with Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent. Completion of these questionnaires will complete subjects' participation in this pilot study.

02

Conditions studied

  • Morquio Disease
  • Mucopolysaccharidosis IV

Keywords

  • Morquio
  • Mucopolysaccharidosis IV
  • Psychological health
03

In context

Osteochondrodysplasias

41 studies on the registry are indexed under Osteochondrodysplasias; 11 are open to participants now.

This study's enrollment of 20 is below the median of 75 across 20 observational studies indexed under Osteochondrodysplasias.

Browse Osteochondrodysplasias studies →

Lead sponsor

Nadia Ali, PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People with Morquio Disease

Inclusion criteria

  1. Documented clinical diagnosis of MPS IV based on clinical signs and symptoms of MPS IV and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IV.
  2. Patient is at least 18 years old.
  3. Patient is not currently receiving enzyme replacement therapy for MPS IV.
  4. Patient must provide written, informed consent prior to study participation.

Exclusion criteria

Exclusion Criteria:

  1. Previous treatment with ERT
  2. Previous hematopoietic stem-cell transplant
  3. Patient has a clinically significant disease (with the exception of symptoms of Morquio), including clinically significant immunologic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would confound the effects of Morquio upon study variables
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. ASEBA Self-Report

    Self-report questionnaire assessing psychological and adaptive functioning well-being

    Time frame: At enrollment, as a single-timepoint only

Secondary outcomes

  1. Brief Pain Inventory

    Self-report measure of subjective pain levels and interference of pain in daily functioning

    Time frame: At enrollment, as a single-timepoint only

  2. SF-36

    Brief self-report measure of quality of life

    Time frame: At enrollment, as a single-timepoint only

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Study locations

1 site
  • Emory University
    Decatur, Georgia 30033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01752296
Lead sponsor
Nadia Ali, PhD
Collaborators
BioMarin Pharmaceutical
Responsible party
Nadia Ali, PhD (Health Psychologist / Instructor, Emory University) — Sponsor-investigator
First posted
Dec 19, 2012
Start date
Jul 2012
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Dec 4, 2013

Study contacts

Nadia Ali, Ph.D.
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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