Phase
Condition
Anxiety Disorders
Panic Disorders
Mood Disorders
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject is male or female outpatients age 18 to 65 years, inclusive
The subject meets DSM-IV criteria for Generalized Anxiety Disorder as determined bythe MINI.
Sexually active female patients of childbearing potential must be practicing at leastone or more the following methods of contraception during the study: intrauterinedevice (IUD), barrier method in combination with a spermicide, oral/hormonalcontraception or abstinence. Female patients of childbearing potential must have anegative pregnancy test prior to receiving study drug.
Written informed consent must be obtained from the subject prior to studyparticipation.
The subject is in good medical health or with chronic medical conditions which arecurrently stable.
No current abuse of alcohol or other substance.
The subject has a total score of 20 or more on the SIGH-A at screening.
The subject has a Clinical Global Impression (CGI) Severity score of 4 or more atscreening.
Exclusion
Exclusion Criteria:
The subject meets DSM-IV criteria for an Axis I diagnosis (other than GAD) as theprimary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) asdetermined by the MINI.
The subject is clinically judged by the investigator to be at risk for suicide or isacutely suicidal as objectively measured by the MINI and MSE.
The subject is clinically judged by the investigator to be at risk for homicide or isacutely homicidal as objectively measured by the MINI and MSE.
The subject has a psychiatric condition that would require inpatient, or partialpsychiatric hospitalization.
Seizure disorders.
Significant history of medical disease (i.e. cardiovascular, hepatic (e.g. cirrhosis,hepatitis B or C) renal, gynecological, musculoskeletal, neurological,gastrointestinal, metabolic, hematological, endocrine, cancer with a metastaticpotential or progressive neurological disorders) which could impair reliableparticipation in the trial or necessitate the use of medication not allowed by thisprotocol.
The subject is pregnant, planning to become pregnant, or nursing. If a subject becomespregnant, she will be discontinued immediately and followed appropriately.
Concomitant therapy with another investigational drug, or participation in aninvestigational drug study within one month prior to entering this study.
Current psychotherapeutic treatment except for treatment with Specific ReuptakeInhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil),Sertraline (Zoloft), Luvox (Fluvoxamine), and Citalopram. Potential subjects mayremain on one of the SSRI medications provided that he or she has been on a stabledose for at least 4 weeks prior to entering this study; this dose remains stablethroughout the remainder of this study; and it can be determined that this medicationis not exacerbating the anxiety symptoms.
History of poor compliance or in the Investigator's judgment patients any subjectwhose treatment as an outpatient would be clinically contraindicated
The subject has attempted suicide one or more times within the past twelve months
The subject has a Structured Hamilton Depression Rating Scale (SIGH-D) score above 38which suggests a moderate to severe clinical level of depressive symptoms
Study Design
Study Description
Connect with a study center
UCLA
Los Angeles, California 90024
United StatesSite Not Available
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