| Methods |
Randomized
Double‐blind
Parallel‐group
Placebo‐controlled
Duration: 12 weeks |
| Participants |
Country: United States
No. of centers: 1
Diagnosis: chronic cerebrovascular insufficiency due to cerebral arteriosclerosis
Diagnosis defined by: Assessment of Clinical Status
Total No. of patients: 59
Age: range (60‐94), Hydergine mean was 77.9, range (60‐94); Placebo mean age was 76.3, range (62‐89).
Sex: Hydergine: 15 females, 10 males; Placebo: 12 females, 13 males
Inclusion: hospitalized geriatric patients suffering from symptoms attributable to diagnosis of chronic cerebrovascular insufficiency due to cerebral arteriosclerosis
Exclusion: psychosis, post‐traumatic brain damage, post‐infective brain disease, cerebral neoplasm, mental deterioration; regular use of psychotropic, sedatives or vasodilator medications 3 weeks prior to study; insufficient symptoms for diagnosis; physical conditions precluding participation; acute physical disorders affecting assessment; expectation of transfer, traumatic events, or discharge before end of study. |
| Interventions |
Route: sublingual
Treatment: Hydergine 1mg t.i.d.
Control: Placebo t.i.d. |
| Outcomes |
Assessment of Clinical Status (19 items, 7‐point rating scale), vitals, labs, physical examination, Drug Reaction Record, Global Rating of Change, Major Symptom Inventory |
| Notes |
No. excluded after randomization: Total = 9. Treatment = 4, Control = 5.
No. not included in analysis: Total = 9. Treatment = 4, Control = 5. |
