Anxiety Disorders Clinical Trial
Official title:
12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
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.
STUDY OBJECTIVES:
The objective of this proposal is to study the efficacy of the medication Seroquel SR for the
treatment of alcohol dependence and co-morbid anxiety in a prospective double blind
placebo-controlled randomized clinical study. Patients, meeting the DSM-IV criteria for
Alcohol Dependence and an Anxiety Disorder, will be enrolled and randomized to receive
placebo or Seroquel SR. All subjects will be referred to usual treatment program, where they
can receive group/self help group therapy.
Method:
This is a 12-week prospective, double blind placebo-controlled randomized clinical trial of
Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric
Disorders (DSM-IV) criteria for alcohol dependence and anxiety disorders. Potential
candidates will be allowed sufficient time to review the consent document and ask questions
about the trial prior to signing the consent document. Consenting adults will be randomized
to receive active medication, Seroquel SR or placebo for 12-weeks. The study will enroll 20
patients, 10 will be randomized to receive Seroquel SR, and 10 will receive placebo. All
participants will also be referred to usual alcohol treatment, including individual, group
and/or self help group therapy (Alcoholics Anonymous).
Subjects will be randomized to receive either Seroquel SR or placebo. Dosing of Seroquel SR
will occur on the following schedule: At the baseline visit, Seroquel SR will be started at
50 mg QHS for Day 1 and 2, and dose increase to 150 mg QHS on day 3-4, and increased further
to 300 mg QHS from day 5-day 42. After day 5, the Seroquel SR dosage can be increased by up
to 100 mg per week to a maximal dose of 400 mg per day. During the treatment period, dose
reductions (because of physical illness or adverse event) are allowed for patients taking at
least 200 mg per day.
;
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 |
NCT05863637 -
Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting
|
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 |
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 |
NCT01333098 -
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
|
Phase 1/Phase 2 |