Anxiety Disorders Clinical Trial
Official title:
12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Verified date | December 2008 |
Source | Creighton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3 approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety disorders is unknown. This study explores the effects of the medication, sustained-release quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures include craving for alcohol, length of sobriety from drinking and level of anxiety with Seroquel SR.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of alcohol dependence and an anxiety disorder (generalized anxiety disorder, post traumatic disorder, panic disorder, obsessive compulsive disorder, etc.) based on Mini-International Neuropsychiatric Interview (MINI) for DSM IV. 2. Subject reports a minimum of 48 standard alcoholic drinks (or an average of 12 drinks/wk) in a consecutive 30-day period (i.e., a minimum of 40% days drinking), and has 2 or more days of heavy drinking (defined as =5 drinks/day in males and =4 drinks/day in females) in this same period as measured by the Time Line Follow Back. 3. Male and female patients between 19-65 years of age. 4. Ability to provide informed consent. 5. Medically and psychiatrically stable defined as not requiring inpatient treatment. Exclusion Criteria: 1. Inability to provide informed consent. 2. Need for inpatient treatment 3. Need for inpatient detoxification for substance other than alcohol 4. Evidence of active dependence on a substance other than alcohol (with the exception of nicotine) as assessed by a urine drug screen. 5. Medically or psychiatrically unstable patients, defined as requiring inpatient treatment. 6. Pregnancy, nursing or refusal to use a reliable method of birth control in women. 7. Current treatment with other antipsychotic medications, which cannot be switched to Seroquel SR. 8. Patients with known allergy to Seroquel IR/SR or treatment failure to Seroquel IR/SR. 9. Exclude patients (pts) with unstable diabetes. 10. Exclude pts over 65 11. Exclude pts with dementia |
Country | Name | City | State |
---|---|---|---|
United States | Creighton University Department of Psychiatry | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Creighton University | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 1: To determine whether Seroquel SR reduces alcohol use and prolongs sobriety as measured by the Time Line Follow Back Method and breathalyzer test in individuals with alcohol dependence and co-morbid anxiety. | Two Years | ||
Secondary | Aim 2: To determine whether Seroquel SR decreases craving as measured by the Pennsylvania Craving Scale, in individuals with alcohol dependence and co-morbid anxiety. | Two Years | ||
Secondary | Aim 3: To determine whether Seroquel SR reduces anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety (HAM-A), in individuals with alcohol dependence and co-morbid anxiety. | Two years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Recruiting |
NCT05419934 -
EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
|
N/A | |
Active, not recruiting |
NCT04136054 -
Better Sleep in Psychiatric Care - Anxiety and Affective Disorders
|
N/A | |
Completed |
NCT04091139 -
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
|
Phase 2/Phase 3 | |
Completed |
NCT04647318 -
Physiological Response to Self-compassion Versus Relaxation
|
N/A | |
Active, not recruiting |
NCT05114824 -
Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Completed |
NCT05078450 -
Mood Lifters Online for Graduate Students and Young Professionals
|
N/A | |
Not yet recruiting |
NCT06162624 -
Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
|
N/A | |
Not yet recruiting |
NCT05747131 -
Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children
|
N/A | |
Not yet recruiting |
NCT05863637 -
Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting
|
N/A | |
Not yet recruiting |
NCT05225701 -
Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders.
|
N/A | |
Completed |
NCT02579915 -
Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC)
|
N/A | |
Recruiting |
NCT02376959 -
Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers
|
N/A | |
Recruiting |
NCT02186366 -
Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type
|
N/A | |
Not yet recruiting |
NCT02126787 -
Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment
|
N/A | |
Completed |
NCT02134730 -
School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial
|
N/A | |
Withdrawn |
NCT01953042 -
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
|
N/A | |
Completed |
NCT01636791 -
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
|
Phase 3 |