The effect of Brintellix as antidepressant for Alzheimer's disease

Randomized, Double-blind placebo-controlled study of Brintelix for the treatment for depression in Alzheimer's Disease.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004083

Enrollment

100

Registered

2019-06-21

Start date

2017-03-09

Completion date

Unknown

Last updated

2019-07-17

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

Conditions

None listed

Interventions

Drug : The study subjects will receive 5mg of the same type of research drug (Brintelix or placebo) per day at the base. After four weeks, the subjects are given an increased dose of 20mg per day if t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?Patients aged 60 years or older who have voluntarily participated in the study and signed an agreement ?Patients who meet the criteria for Alzheimer's dementia of NINCDS-ADRDA ?Patients with three or more symptoms on Olin Diagnosis Criteria for Depression in Alzheimer's Dementia ?Patients with a CDR score of 0.5 to 2 ?Patients with a MMSE-KC score of 10 to 26 ?Patients with a SGDS-K score of 5 or more ?Patients with care giver who can accompany all study visits

Exclusion criteria

Exclusion criteria: ?Patient with a history of taking antidepressants within 4 weeks ?Patient who was given memantine in at least four weeks ?Patients with other major mental disorders ?Patients with triple normal levels of AST or ALT liver function ?Patient showing evidence of severe cerebrovascular disease. ?Patient showing evidence of critical or unstable internal medicine (e.g., uncontrolled diabetes with symptoms) ?Patients with evidence of Parkinson's disease, stroke, brain tumor or normal brain pressure hydrocephalus ?Patient with a history of alcohol or other drug abuse

Design outcomes

Primary

Measure	Time frame
depressive symptom	—

Secondary

Measure	Time frame
SVLT(Seoul Verbal Learning Test)-immediate recall;SVLT(Seoul Verbal Learning Test)-delayed recall;SVLT(Seoul Verbal Learning Test)-recognition;digit span test;Contrasting program;Go-no-go;DSST(Digit Symbol Substitution Test);S-IADL(Seoul-Instrumental Activities of Daily Living);BDS-ADL(Blessed Dementia Scale-Activities of Daily Living)	—

Countries

Korea, Republic of

Contacts

Public ContactDo Hoon Kim

Hallym University Medical Center- Chuncheon

dhkim0824@gmail.com+82-33-240-5277

Outcome results