Combined Treatment for Generalized Anxiety Disorder (GAD)

NCT00620776 | Completed Phase 2 Results DMC

• 2 other identifiers: 8023075R34MH072678-02
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Cognitive Behavioral Therapy; Psychotherapy plus medication; Combined treatment

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate and 25-30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.

  Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24

Secondary Outcomes (11)

• Hospital Anxiety Depression Scale (HAD)-Anxiety Score

  Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24

• Hospital Anxiety Depression Scale (HAD)-Depression Score

  Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24

• Hamilton Rating Scale for Depression (HAM-D)-17-item Score

  Data collected as part of protocol 709012 at baseline, week 12, and week 24

• Clinical Global Impression (CGI)-Severity Score

  Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24

• Clinical Global Impression (CGI)-Improvement Score

  Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24

Study Arms (2)

Combined Treatment

EXPERIMENTAL

Patients who receive combined cognitive behavioral therapy (CBT) plus medication (venlafaxine XR, flexibly dosed between 75-225 mg/day) treatment for GAD. CBT was once/week sessions for 12 weeks. Medication continued for the full 6 months.

Behavioral: Cognitive Behavioral Therapy; Drug: Venlafaxine XR

Venlafaxine XR 75-225 mg alone

ACTIVE COMPARATOR

These patients receive only medication treatment for GAD. Patients take venlafaxine (flexibly dosed from 75-225 mg/day) as part of NCT00183274 and are assessed over a 6 month period. Medication continued for the full 6 months.

Drug: Venlafaxine XR

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.

Combined Treatment

Venlafaxine XR DRUG

Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).

Also known as: Effexor extended release

Combined Treatment; Venlafaxine XR 75-225 mg alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GAD diagnosis by structured interview
• Hamilton Anxiety Scale score of 18 or less
• Clinical Global Impressions Scale score of at least 4
• Hamilton Depression Scale score of 18 or less
• Hamilton Depression Scale suicide item score less than 2
• Use of an effective form of contraception throughout the s

You may not qualify if:

• Hypersensitivity to venlafaxine XR
• History of seizures
• Episode of major depressive disorder in the previous 6 months
• History of any psychotic illness, bipolar disorder, or dementia
• Substance abuse and dependence during the past 6 months
• Other anxiety disorders with the exception of social phobia as long as GAD is primary
• Regular use of anxiolytics or antidepressants within 7 days of study onset
• Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
• Use of other psychotic medication besides benzodiazepines

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania, 3535 Market Street, Suite 650

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Only one-third of those approached to add on CBT were interested in this option. Strict exclusion criteria reduces the generalizability of the study results. Possible that other forms of CBT treatment may produce different results.

Results Point of Contact

• Title: Dr. Paul Crits-Christoph
• Organization: University of Pennsylvania

crits@mail.med.upenn.edu

(215) 662-7993

Study Officials

• Paul Crits-Christoph, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology in Psychiatry

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: October 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 16, 2017
• Results First Posted: February 16, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)