Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

NCT01089075 | Terminated Phase 4

• 1 other identifier: 2009-014909-14
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function.

Conditions

Partial Corticotrope Insufficiency

Keywords

neuropsychological effects of hydrocortisone replacement

Outcome Measures

Primary Outcomes (1)

• Changes in score of alertness test (TAP)- interindividual differences

  day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)

Secondary Outcomes (1)

• Changes in score of Alertness Test (TAP) - intraindividual differences

  day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)

Study Arms (2)

placebo/20 mg hydrocortisone

PLACEBO COMPARATOR

Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone

Drug: Hydrocortisone; Drug: Placebo

20 mg hydrocortisone/placebo

ACTIVE COMPARATOR

Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo

Drug: Hydrocortisone; Drug: Placebo

Interventions

Hydrocortisone DRUG

20 mg po for 7 days (2 tablets)

Also known as: Hydrocortison GALEN 20 mg

20 mg hydrocortisone/placebo; placebo/20 mg hydrocortisone

Placebo DRUG

2 tablets po

Also known as: P-Tabletten 7 mm Lichtenstein

20 mg hydrocortisone/placebo; placebo/20 mg hydrocortisone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (male and female) between 18 and 75 years
• month after TBI or SAH before prescreening
• Cortisol level 100-180 ng/ml after stimulation with ACTH
• Written informed consent by patient or a legally accepted representative

You may not qualify if:

• Pregnancy and lactation period (during study treatment)
• Concomitant or previous high-dose therapy with glucocorticoids; previous treatment with glucocorticoids will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 months before study participation
• Suspected or known hypersensitivity to hydrocortisone or any of its components
• Albumine less than 2,5 g/dl
• Suspected or known drug or alcohol abuse
• Planned treatment for thyroid dysfunction or a planned change in established thyroid treatment
• Participation in another clinical trial with investigational new drugs
• Severe medical or psychiatric disease
• Change of dosage of any other drug which might influence the corticotrope axis or cognitive function (e.g. antidepressive treatment) during the last 3 weeks
• Oral contraceptives
• Severe disturbances in articulation, visual faculty or hearing
• Any elective surgery or medical treatment planned in the observation period
• Intensive Care treatment

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Schön Klinik Bad Aibling

Bad Aibling, Bavaria, 83043, Germany

Location

Related Links

• Click here for more information about endocrinological diseases

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Günter K. Stalla, Prof. Dr.

  Max-Planck-Institute, Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: March 18, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

DE (1)