Trial of Hydrocortisone for Post-Traumatic Stress Disorde... | NCT00706173

Studies
Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)

NCT00706173

Sponsor

University of California, San Diego

Status

Withdrawn

Last Update Posted

Jun 3, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Post-traumatic Stress Disorder

Interventions

Hydrocortisone
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit eligible subjects for the trial.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Jun 25, 2008

First Submission Date that Met QC Criteria

Jun 25, 2008

First Posted Date

Jun 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. The investigators propose to replicate findings of an earlier published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do so in a more meaningful way, the investigators will conduct a larger but similar randomized double-blind placebo-controlled, cross-over design treatment study examining the use of low dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.

The investigators hypothesize that, as described by Aerni et al. (2004), administration of daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for re-experiencing types (e.g., flashbacks, nightmares)of symptoms. The investigators also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrocortisone	Experimental		Drug: Hydrocortisone
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrocortisone	Drug	Hydrocortisone 10-20 mg PO daily for 4 weeks.	Hydrocortisone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinician Administered PTSD Scale (CAPS)		Week 0,2,4,6,8,10
Clinical Global Impressions - Improvement (CGI-I)		Week 0,2,4,6,8,10

Secondary Outcomes

Measure	Description	Time Frame
Sheehan Disability Inventory (SDI)		Week 0,4,6,10
Brief Symptom Inventory - 18 item (BSI-18)		Week 0,2,4,6,8,10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male military veterans
Between the ages of 18-65 years old
Generally good medical health with no clinically significant abnormalities on physical examination, electrocardiogram, or laboratory findings
Ability to provide informed consent and comply with requirements of study protocol
No specific contraindications to hydrocortisone
Clinically predominant DSM-IV diagnosis of PTSD
Score of ≥ 40 on Clinician Administered PTSD Scale [CAPS]

Exclusion Criteria:

History of moderate to severe traumatic brain injury, seizure or organic mental illness
Lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or depression with a score of ≥ 16 on the 17-item Hamilton Depression Rating Scale (Hamilton, 1960), active suicidal ideation
Unstable medical illness
Subjects undergoing any formal psychotherapy within 3 months of enrollment
Subjects that meet criteria for substance dependence during the last 6 months
History of adverse reaction to corticosteroids.
Concurrent use of other psychotropic medication (e.g. benzodiazepines, antipsychotics)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Murray B Stein, MD, MPH	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego		La Jolla	California	92037	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15285979	Background	Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.
11750894	Background	Schelling G, Briegel J, Roozendaal B, Stoll C, Rothenhausler HB, Kapfhammer HP. The effect of stress doses of hydrocortisone during septic shock on posttraumatic stress disorder in survivors. Biol Psychiatry. 2001 Dec 15;50(12):978-85. doi: 10.1016/s0006-3223(01)01270-7.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473