Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00701675 · ClinicalTrials.gov registry record · Phase 4
Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly
A Phase 4 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT00701675: Completed Phase 4 study, sponsored by VA Office of Research and Development.
NCT00701675 is a Phase 4 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00701675, a Phase 4 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG sertraline 50 mg daily
- DRUG sertraline 100 mg daily
- DRUG Placebo 50 or 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2005-10 |
| Est. Completion | 2009-09 |
| Phase | Phase 4 |
What the finished NCT00701675 record still lists
NCT00701675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which sertraline 50 mg daily is the first listed.
NCT00701675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00701675 about?
NCT00701675 is a clinical study titled "Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly". 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...
What is the current status of trial NCT00701675?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2005-10. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00701675?
The interventions under investigation include: sertraline 50 mg daily (DRUG), sertraline 100 mg daily (DRUG), Placebo 50 or 100 mg (DRUG).
Who is sponsoring clinical trial NCT00701675?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00701675's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02852213 · 42 participants · Phase 1
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
- NCT03136146 · 42 participants · Phase 2
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
- NCT03178149 · 42 participants · Phase 1
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- NCT03663530 · 42 participants · NA
Circadian Misalignment and Energy Balance
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia