Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00736021 |
|
Recruitment Status :
Completed
First Posted : August 15, 2008
Last Update Posted : March 23, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic events.
Forty survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks
Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks.
The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward).
The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stress Disorders, Post Traumatic | Drug: Escitalopram | Not Applicable |
The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD)
Forty adult survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks
Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks.
The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward).
The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 38 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | March 2010 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: A
Single arm (open label study): Provide twelve weeks of treatment with high does (40 mg daily) of escitalopram to trauma survivors with chronic PTSD.
|
Drug: Escitalopram
Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily
Other Name: Lexapro, Cipralex |
- Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS) [ Time Frame: Twelve Weeks on Active Medication ]
- Proportion of Participants completing the study [ Time Frame: twelve weeks of active treatment ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult survivors of traumatic events with chronic PTSD
Exclusion Criteria:
- Individuals with past history of psychotic disorder, bipolar disorder, opiate or stimulants abuse.
- Individuals currently on anti-depressant therapy.
- Individuals with past history of a failure to respond to escitalopram
- Pregnant Women
- Medical condition excluding the treatment with escitalopram (e.g., renal or hepatic insufficiency). Current, life threatening medical illness. History or severe side effects with escitalopram (e.g., hyponatremia)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736021
| Israel | |
| Hadassah University Hospital | |
| Jerusalem, Israel, 91120 | |
| Principal Investigator: | Areh Y SHALEV, M.D. | Hadassah Medical Organization |
| Responsible Party: | Arieh Y. Shalev, M.D., Department of Psychiatry, Hadassah University Hospital, Jerusalem, Israel |
| ClinicalTrials.gov Identifier: | NCT00736021 |
| Other Study ID Numbers: |
HMO_SHALEV_02 |
| First Posted: | August 15, 2008 Key Record Dates |
| Last Update Posted: | March 23, 2010 |
| Last Verified: | September 2008 |
|
PTSD Pharmacological Treatment SSRI Escitalopram Anxiety Disorders |
|
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |