Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

NCT00701675 | Completed Phase 4 Results DMC

• 1 other identifier: CLIN-005-04F
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However, despite such high prevalence treating clinicians are presently forced to address treatment issues in this population without the guidance of scientific data. This proposal aims to begin to address this void. In light of emerging information regarding efficacy of the newer anti anxiety agents, specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young adult GAD patients it is time to prospectively evaluate the safety and efficacy of these medications in the treatment of elderly GAD patients. Therefore, this study will examine the effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for older patients with GAD.

Conditions

Generalized Anxiety Disorder

Keywords

sertraline; pharmacotherapy; geriatric

Outcome Measures

Primary Outcomes (1)

• Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg

  Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of \<17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.

  11 weeks from baseline

Study Arms (3)

Sertraline 50mg

EXPERIMENTAL

sertraline 50 mg daily

Drug: sertraline 50 mg daily

Sertraline 100mg

EXPERIMENTAL

sertraline 100mg daily

Drug: sertraline 100 mg daily

Placebo

PLACEBO COMPARATOR

placebo 50 or 100mg

Drug: Placebo 50 or 100 mg

Interventions

sertraline 50 mg daily DRUG

50 mg daily

Also known as: zoloft 50 mg daily

Sertraline 50mg

sertraline 100 mg daily DRUG

100 mg daily

Also known as: zoloft 100mg daily

Sertraline 100mg

Placebo 50 or 100 mg DRUG

50mg or 100mg matching placebo

Also known as: 50mg or 100mg matching placebo

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of any race, ages 60 years and older.
• Willingness to accept randomization.
• Subjects who meet current (Diagnostic and Statistical Manual of Psychiatric Disorders forth edition (DSM-IV) criteria for a principal diagnosis of GAD
• Patients must have a minimum of a "moderately ill" rating on the Clinicians Global Impression-Severity Scale for GAD.
• Patients will have a score of 10 or more on the Hospital Anxiety and Depression Rating Scale (HADS) Anxiety subscale.
• Subjects entering the study will be free of psychotropic medications.

You may not qualify if:

• Subjects with DSM-IV current major depressive episode will be excluded.
• Subjects who exhibit suicidal ideation or are judged to be a significant suicide risk.
• Subjects who meet DSM-IV criteria for a substance (drug and alcohol) abuse and dependence disorder within the past 6 months
• Subjects who meet current or past DSM-IV criteria for psychotic disorder, or bipolar disorder.
• Subjects who meet DSM-IV criteria for dementia.
• Subjects with DSM-IV current major depressive episode will be excluded.
• Subjects who exhibit suicidal ideation or are judged to be a significant suicide risk.
• Subjects who meet DSM-IV criteria for a substance (drug and alcohol) abuse and dependence disorder within the past 6 months
• Subjects who meet current or past DSM-IV criteria for psychotic disorder, or bipolar disorder.
• Subjects who meet DSM-IV criteria for dementia.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Medical Center, Tuscaloosa

Tuscaloosa, Alabama, 35404, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Ralph H Johnson VA Medical Center, Charleston

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Olga Brawman-Mintzer, MD
• Organization: Ralp H. Johnson VA Medical Center

mintzero@musc.edu

8437242302

Study Officials

• Olga Brawman-Mintzer, MD

  Ralph H Johnson VA Medical Center, Charleston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: October 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Locations

US (3)