Anxiety Disorders Clinical Trial
Official title:
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)
| Verified date | April 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
| Status | Completed |
| Enrollment | 725 |
| Est. completion date | May 2009 |
| Est. primary completion date | May 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Signed informed consent before any study-related procedures start. - The patient is previously diagnosed with Generalized Anxiety Disorder. - The patient has a HADS-A (anxiety) score =10 at both screening and randomization. Exclusion Criteria: - Patient has a lifetime history of schizophrenia or other psychotic disorders - Patient has a history of seizures or seizure disorder. - Patient is pregnant or breast feeding. - Patient has received electroconvulsive treatment (ECT) in the past. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Arcadia | California |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Beechwood | Ohio |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Bismarck | North Dakota |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Cambridge | Massachusetts |
| United States | Research Site | Cerritos | California |
| United States | Research Site | Chino | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clementon | New Jersey |
| United States | Research Site | Encino | California |
| United States | Research Site | Fresh Meadows | New York |
| United States | Research Site | Friendswood | Texas |
| United States | Research Site | Ft Myers | Florida |
| United States | Research Site | Herndon | Virginia |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Jenkintown | Pennsylvania |
| United States | Research Site | Libertyville | Illinois |
| United States | Research Site | Los Alamitos | California |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Middleburg Heights | Ohio |
| United States | Research Site | Middleton | Wisconsin |
| United States | Research Site | Mount Kisco | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Norristown | Pennsylvania |
| United States | Research Site | Norwich | Connecticut |
| United States | Research Site | Novato | California |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Park Ridge | Illinois |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Smyrna | Georgia |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | St Petersberg | Florida |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Winston-salem | North Carolina |
| United States | Research Site | Winter Park | Florida |
| United States | Research Site | Woodstock | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum. | From randomization (baseline) to week 4 | No |
| Secondary | Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms. | From randomization (baseline) to week 4 | No |
| Secondary | Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score | The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms. | From baseline (randomization) to week 4 | No |
| Secondary | Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score | The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms | From baseline ( randomization) to week 4 | No |
| Secondary | Change in Sheehan Disability Scale (SDS) Global Total Score | The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired) | From baseline ( randomization) to week 4 | No |
| 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 |
NCT02186366 -
Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type
|
N/A | |
| Recruiting |
NCT02376959 -
Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers
|
N/A | |
| Not yet recruiting |
NCT02126787 -
Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment
|
N/A | |
| Withdrawn |
NCT01953042 -
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
|
N/A | |
| Completed |
NCT02134730 -
School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial
|
N/A | |
| Completed |
NCT01333098 -
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders
|
Phase 1/Phase 2 |