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The Skeletal Effects of SSRIs | Do Serotonin Reuptake Inhibitors (SSRIs) Affect Bone Mass in Adolescents

The Skeletal Effects of SSRIs research study

What is the primary objective of this study?

Building on findings from animal studies, pediatric clinical trials, epidemiologic research in adults, and on preliminary findings from the investigators' laboratory in children and adolescents, this project aims to investigate whether selective serotonin reuptake inhibitors (SSRIs), a group of widely-used psychotropics, are associated with impaired bone mineralization in youths. Establishing such an association is a first step in a process that would eventually involve developing preventative interventions. Identifying genetic factors that place certain youths at higher risks for this side effect would ultimately allow clinicians to tailor treatment to the needs and vulnerabilities of each youth, moving the field closer towards individualized medicine.

Who is eligible to participate?

Inclusion Criteria: 1. Age 15 to 20 years old (inclusive). 2. Treatment with an SSRI, regardless of the indication, having been started within one month. This criterion does not apply to controls. SSRIs include: fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine. 3. Ability to provide consent. Exclusion Criteria: 1. Age- and sex-adjusted height Z-score < -2 or > 2. 2. Concomitant treatment with other antidepressants, psychostimulants, or mood stabilizers and antipsychotics. Treatment with benzodiazepines, low dose trazodone, alpha-2 agonists, and antihistaminergic agents will be allowed. 3. Presence of illicit drug and/or alcohol dependence. 4. Pregnancy. 5. Primary bone diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis). 6. Potential secondary bone disease (e.g., due to chronic inflammatory diseases, diabetes, hypo- or hyperparathyroidism, hyperthyroidism, growth hormone deficiency, and other endocrine disturbances, history of childhood cancer, or prior transplantation). 7. Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain) and congenital disorders. 8. Malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease) or lead poisoning. 9. Chronic use of drugs affecting bone metabolism (e.g., oral corticosteroids). 10. Inability to cooperate with the BMD measurements. 11. Eating disorders, due to their potential effect on BMD. 12. If a senior in high school, plan to join an out-of-state college.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

The Skeletal Effects of SSRIs

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SSRI GroupParticipants within one month of starting an SSRI

Unmedicated GroupNo treatment with SSRIs

Study Status

Completed

Start Date: September 2010

Completed Date: April 2016

Phase:

Type: Observational

Design:

Primary Outcome: Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race)

Secondary Outcome: Lumbar Spine Bone Mineral Density (BMD) Z-score

Study sponsors, principal investigator, and references

Principal Investigator: Chadi Calarge, MD

Lead Sponsor: Chadi A. Calarge

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT02147184

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