Cortisol Augmentation of Prolonged Exposure Therapy | NCT00751855

Studies
Cortisol Augmentation of Prolonged Exposure Therapy

NCT00751855

Sponsor

VISN 3 Mental Illness Research, Education and Clinical Center

Status

Completed

Last Update Posted

Jul 27, 2012Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

PTSD

Interventions

Prolonged Exposure therapy
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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Sep 11, 2008

First Submission Date that Met QC Criteria

Sep 11, 2008

First Posted Date

Sep 12, 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

Jul 26, 2012

Last Update Posted Date

Jul 27, 2012Estimated

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

This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Prolonged Exposure therapy with Hydrocortisone	Behavioral: Prolonged Exposure therapy Drug: Hydrocortisone
2	Placebo Comparator	Prolonged Exposure therapy with placebo	Behavioral: Prolonged Exposure therapy Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolonged Exposure therapy	Behavioral	10 weekly sessions	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)		Baseline (Week 0), endpoint (week 11)

Secondary Outcomes

Measure	Description	Time Frame
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)		Baseline (Week 0), endpoint (week 11)
Other measures of clinical outcome, psychological state and functioning		Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
Capable of understanding, reading and writing English

Exclusion Criteria:

Incapable and/or unwilling to provide written informed consent prior to participation
Unwilling and/or unable to discontinue current psychotherapy
Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
Regular use of oral or inhaled steroids
Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study
Morbid obesity (VMI > 40)
Clinically significant laboratory abnormalities as determine during medical clearance procedures
For women, a positive pregnancy test
Heavy smoking (more than 2 packs a day)
Substance and/or alcohol abuse and/or dependence within the previous 6 months
Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk
Current psychosocial problems that might interfere with treatment compliance
A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Jul 22, 2013
Reset	Sep 24, 2013
Release	Sep 25, 2013
Reset	Nov 26, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 22, 2013			Sep 24, 2013
Sep 25, 2013

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