Phase 3 N=11 Randomized Double-blind Treatment

Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency

Hypopituitarism

Bottom Line

View on ClinicalTrials.gov: NCT01007071 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Human Growth Hormone (1-134) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI	—	—
SECONDARY Neuropsychological Testing of Executive Function	69.4; 77.6	—

Summary

Patients with Growth hormone (GH) deficiency often report impaired quality of life and difficulty with mental functioning. It has been suggested that GH replacement in such patients leads to improvement in cognitive function. The aim of this study is to elucidate the effects of GH replacement in patients with GH deficiency on cognitive function using structural and functional neuroimaging and cognitive testing.

Eligibility Criteria

Inclusion Criteria

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age 18-65 years old
Both men and women
Naive to GH replacement therapy
Diagnosis of Growth Hormone deficiency, adult onset
Good general health
Normal thyroid, adrenal or gonadal function, or stable thyroid, glucocorticoid (at replacement doses) and gonadal replacement therapy for at least 3 months prior to study initiation. If subjects are receiving transdermal testosterone, attainment of mid-normal serum values will be considered adequate. If subjects are on intramuscular testosterone, attainment of mid-normal serum testosterone at mid-injection cycle will be considered adequate

Exclusion Criteria

Pregnancy (positive pregnancy test) prior to enrollment in the study
Any other condition that the investigator believes would pose a significant hazard to the subject if Growth Hormone therapy was initiated
Idiopathic Growth Hormone Deficiency
DSM IV diagnosis of Major Depressive Disorder with or without psychotic features, Bipolar II Disorder with or without psychotic features in a major depressive episode
Current use of psychotropic medications
History of moderate to severe brain injury
Clinically significant cardiovascular disease
Anemia with hct 2.0
Recent history of excessive alcohol use
Participation in another simultaneous medical investigation or trial
Active neoplasm
Prader Willi Syndrome
History of brain radiation
Chemotherapy, past or present use
History of head or eye injury involving persistent metal fragments, and implanted electrical device (such as a heart pacemaker)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01007071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.