Clinical trial NCT00237393: Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)
Official title: A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PTSD
Keywords: PTSD
Posttraumatic stress disorder
Treatment
Quetiapine
Lead sponsor: Ralph H. Johnson VA Medical Center
Sponsor class: FED
Collaborators: name: AstraZeneca
First posted: 2005-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
Secondary outcomes:
measure: Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
measure: Hamilton Depression Rating Scale (HAMD)
measure: Hamilton Rating Scale of Anxiety (HAMA)
measure: Clinical Global Impression Severity Scale (CGI-S)
measure: Clinical Global Impression Improvement Scale (CGI-I)
measure: Davidson Trauma Scale (DTS)
measure: Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
measure: SDS
measure: Arizona Sexual Experience Scale (ASEX)
measure: AIMS
measure: BAS
measure: SAS
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: NM VA Healthcare System
state: New Mexico
city: Charleston
country: United States
facility: Ralph H. Johnson VAMC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VAMC/Medical University of South Carolina
name: Mark B Hamner, MD
role: PRINCIPAL_INVESTIGATOR
References: