Trial record 1 of 6 for: PTSD and CRF

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Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder

This study has been completed.

Sponsor:

Collaborator:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Boadie W. Dunlop, Emory University

ClinicalTrials.gov Identifier:

NCT01018992

First received: November 6, 2009

Last updated: January 24, 2017

Last verified: January 2017

History of Changes

Results First Received: July 2, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Investigator; Primary Purpose: Diagnostic
Condition:	Stress Disorders, Post-Traumatic
Interventions:	Drug: GSK561679 Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from Emory University School of Medicine, Mount Sinai School of Medicine, Baylor College of Medicine, and the University of California San Francisco between January 2010 and June 2014.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects stopped psychotropic medications (w/ the exception of zolpidem, eszopiclone, and zaleplon for insomnia) w/in 2 weeks (6 weeks for fluoxetine) of Visit 1. Patients on ineffective psychotropic medications tapered off by the patients’ prescribing doctor. 139 subjects did not proceed to randomization due to meeting exclusionary criteria.

Reporting Groups

	Description
GSK561679	Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Placebo	Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks

Participant Flow: Overall Study

	GSK561679	Placebo
STARTED	63	65
COMPLETED	47	49
NOT COMPLETED	16	16
Adverse Event	8	3
Withdrawal by Subject	3	8
Protocol Violation	0	4
Lost to Follow-up	5	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants randomized to receive the double-blind study medication

Reporting Groups

	Description
GSK561679	Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Placebo	Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
Total	Total of all reporting groups

Baseline Measures

	GSK561679	Placebo	Total
Overall Participants Analyzed [Units: Participants]	63	65	128

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%	0 0.0%	0 0.0%
Between 18 and 65 years	63 100.0%	65 100.0%	128 100.0%
>=65 years	0 0.0%	0 0.0%	0 0.0%

Sex: Female, Male [Units: Participants] Count of Participants
Female	63 100.0%	65 100.0%	128 100.0%
Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

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1. Primary:

Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score [ Time Frame: Baseline, Week 6 ]

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2. Secondary:

Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline [ Time Frame: Baseline, Week 6 ]

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3. Secondary:

Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline, Week 6 ]

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4. Secondary:

Safety, Measured by the Number of Subjects That Experienced an Adverse Event [ Time Frame: Week 6 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of this trial include short duration of treatment (6 weeks) and generalizability due to study population composed of only females.

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Boadie Dunlop
Organization: Emory University
phone: 404-727-8474
e-mail: bdunlop@emory.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dunlop BW, Rothbaum BO, Binder EB, Duncan E, Harvey PD, Jovanovic T, Kelley ME, Kinkead B, Kutner M, Iosifescu DV, Mathew SJ, Neylan TC, Kilts CD, Nemeroff CB, Mayberg HS. Evaluation of a corticotropin releasing hormone type 1 receptor antagonist in women with posttraumatic stress disorder: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:240. doi: 10.1186/1745-6215-15-240.

Responsible Party:	Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier:	NCT01018992 History of Changes
Other Study ID Numbers:	IRB00022717 MH069056 ( Other Identifier: Other )
Study First Received:	November 6, 2009
Results First Received:	July 2, 2015
Last Updated:	January 24, 2017

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