Anxiety Disorders, Generalized Anxiety Disorder
Conditions
Keywords
Anxiety, Elderly, Aged, Serotonin Reuptake Inhibitors, SSRI, SERT
Brief summary
This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.
Detailed description
GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment. Participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur.
Interventions
DRUGEscitalopram
Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of at least moderately severe generalized anxiety disorder (GAD)
Exclusion criteria
* Serious suicide risk or psychiatric instability that would affect study participation * Dementia * Substance abuse, such as alcoholism, within 6 months prior to study entry * Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder * Unstable medical conditions that would preclude the use of escitalopram * Use of certain psychotropics that can not be safely tapered or discontinued for at least 2 weeks prior to and during the study * Use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Using Clinical Global Impressions-Improvement Scale (CGI-I) | Measured at Weeks 1-12 | Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Measured at Week 12 | Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment). |
Countries
United States
Participant flow
Recruitment details
257 subjects consented (177 randomized and received treatment)
Pre-assignment details
78 excluded from randomization due to ineligibility and/or refusal; 2 excluded after randomization but did not start treatment
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants will receive a placebo. | 92 |
| Escitalopram Participants will receive escitalopram. | 85 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Physician Decision | 13 | 13 |
Baseline characteristics
| Characteristic | Escitalopram | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 85 Participants | 92 Participants | 177 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 71.1 years STANDARD_DEVIATION 7.4 | 72.2 years STANDARD_DEVIATION 8.2 | 71.6 years STANDARD_DEVIATION 9.9999 |
| Region of Enrollment United States | 85 participants | 92 participants | 177.0 participants |
| Sex: Female, Male Female | 61 Participants | 58 Participants | 119 Participants |
| Sex: Female, Male Male | 24 Participants | 34 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 92 | 65 / 85 |
| serious Total, serious adverse events | 0 / 92 | 0 / 85 |
Outcome results
Primary
Response Using Clinical Global Impressions-Improvement Scale (CGI-I)
Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).
Time frame: Measured at Weeks 1-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Response Using Clinical Global Impressions-Improvement Scale (CGI-I) | 51 participants |
| Escitalopram | Response Using Clinical Global Impressions-Improvement Scale (CGI-I) | 69 participants |
Secondary
Quality of Life
Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).
Time frame: Measured at Week 12
Population: Quality of Life scales were collected on all participants randomized to Escitalopram and placebo
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Quality of Life | Week 12 SF-36 Role-Emotional Impairment | 62.50 units on a scale | Standard Deviation 37.8 |
| Placebo | Quality of Life | Week 0 SF-36 Role-Emotional Impairment | 42.19 units on a scale | Standard Deviation 36.72 |
| Escitalopram | Quality of Life | Week 0 SF-36 Role-Emotional Impairment | 53.42 units on a scale | Standard Deviation 38.39 |
| Escitalopram | Quality of Life | Week 12 SF-36 Role-Emotional Impairment | 56.16 units on a scale | Standard Deviation 38.83 |