A Placebo-Controlled Study of Pregabalin in Elderly Patients With Generalized Anxiety Disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000955-40-LV

Enrollment

Registered

2004-08-05

Start date

2004-09-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Interventions

Trade Name: Lyrica Pharmaceutical Form: INN or Proposed INN: gamma-aminobutyric acid analogue ((S)-3 (aminomethyl)-5-methylhaxanoic acid Concentration unit: mg milligram(s) Concentration type: range

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or nonfertile female outpatients 65 years or older with a DSM-IV diagnosis of generalized anxiety disorder (GAD) and confirmed using a structured clinical interview (MINI). Patients will have a Hamilton Anxiety Rating Scale (HAM-A) score of ?20 at screening and randomization. Patients will have an Mini-Mental State Examination of Folstein (MMSE) total score ?24. Patients will be in general good health. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will not be using any psychotropic medications. They can not have initiated any formal psychodynamic, cognitive, or behavioral psychotherapy within 3 months of beginning this study. Patients should not be at risk of suicide per the investigator’s clinical judgement. Patients with previous exposure to pregabalin are excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the efficacy of pregabalin versus placebo in relieving the symptoms of Generalized Anxiety Disorder as measured by Hamilton Anxiety Rating Scale (HAM-A) 2. Evaluate the safety of pregabalin versus placebo based upon the nature, incidence and severity of adverse events ;Secondary Objective: 1. Evaluate response rates between pregabalin and placebo (defined as equal or > 50% improvement in HAM-A total score from baseline to last observation on double-blind treatment) 2. Compare the effects of pregabalin and placebo in relieving the symptoms of depression as measured on by the 17-item Hamilton Depression Rating Scale (HAM-D) 3. Compare the effects od pregabalin and placebo on the clinician-rated Clinical Global Impression of Change (CGIC) 4. Compare the effects of pregabalin and placebo on symptoms of psychopathology and psychological distress using the 90-Item Symptom Checklist-Revised (SCL-90-R) total score and subscales 5. Compare the effects od pregabalin and placebo on cognition using the Mini-Mental State Examination of Folstein (MMSE). ;Primary end point(s): Change from baseline to end point in the HAM-A total score	—

Measure

Time frame

Main Objective: 1. To evaluate the efficacy of pregabalin versus placebo in relieving the symptoms of Generalized Anxiety Disorder as measured by Hamilton Anxiety Rating Scale (HAM-A) 2. Evaluate the safety of pregabalin versus placebo based upon the nature, incidence and severity of adverse events ;Secondary Objective: 1. Evaluate response rates between pregabalin and placebo (defined as equal or > 50% improvement in HAM-A total score from baseline to last observation on double-blind treatment) 2. Compare the effects of pregabalin and placebo in relieving the symptoms of depression as measured on by the 17-item Hamilton Depression Rating Scale (HAM-D) 3. Compare the effects od pregabalin and placebo on the clinician-rated Clinical Global Impression of Change (CGIC) 4. Compare the effects of pregabalin and placebo on symptoms of psychopathology and psychological distress using the 90-Item Symptom Checklist-Revised (SCL-90-R) total score and subscales 5. Compare the effects od pregabalin and placebo on cognition using the Mini-Mental State Examination of Folstein (MMSE). ;Primary end point(s): Change from baseline to end point in the HAM-A total score

—

Countries

Latvia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026