Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.

Detailed Description
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Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms. Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy. Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.

Official Title
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A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD

Conditions
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PTSD

Intervention / Treatment
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* Drug: Quetiapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD. Score of at least 50 on the CAPS-SX at baseline. Competent to give informed consent. If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential. Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase. Other medications, if any, must have been kept stable for at least one month prior to randomization. Exclusion Criteria: History of sensitivity to quetiapine Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period. Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease. Medical disorders that may cause or exacerbate anxiety symptoms. Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria. Schizophrenia, schizoaffective disorder, or bipolar disorder. Suicidal or homicidal ideation or other clinically significant dangerousness Currently seeking compensation or increase in compensation for the effects of the trauma. Initiation or change in psychotherapy within 3 months of randomization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Quetiapine | Drug: Quetiapine<br>* Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Week 12 scores on Positive and Negative Syndrome Scale (PANSS) |  |  | 
| Hamilton Depression Rating Scale (HAMD) |  |  | 
| Hamilton Rating Scale of Anxiety (HAMA) |  |  | 
| Clinical Global Impression Severity Scale (CGI-S) |  |  | 
| Clinical Global Impression Improvement Scale (CGI-I) |  |  | 
| Davidson Trauma Scale (DTS) |  |  | 
| Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A) |  |  | 
| Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) |  |  | 
| SDS |  |  | 
| Arizona Sexual Experience Scale (ASEX) |  |  | 
| AIMS |  |  | 
| BAS |  |  | 
| SAS |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Posttraumatic stress disorder, Treatment, Quetiapine