Citalopram for Agitation in Alzheimer's Disease
Condition: Alzheimer's Disease; Agitation
MeSH terms: Alzheimer Disease; Psychomotor Agitation
Intervention: citalopram; placebo
Intervention description: target dose 30mg daily for 9 weeks; daily for 9 weeks
Intervention MeSH terms: Citalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 186.0
Sex: All
Healthy volunteers: No
Keywords: neuropsychiatric symptoms; aggression; mood lability

Summary:

      The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation
      in Alzheimer's dementia.
    

Eligibility criteria:

        Inclusion criteria

          -  Probable Alzheimer's disease (National Institute of Neurological and Communicative
             Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association
             criteria), with Mini-Mental score of 5-28 inclusive

          -  A medication for agitation is appropriate, in the opinion of the study physician

          -  Clinically significant agitation for which either

               1. the frequency of agitation as assessed by the Neuropsychiatric Inventory (NPI) is
                  'Very frequently', or

               2. the frequency of agitation as assessed by the NPI is 'Frequently' AND the
                  severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'

          -  Provision of informed consent for participation in the study by patient or surrogate
             (if necessary) and caregiver

          -  Availability of primary caregiver, who spends several hours a week with the patient
             and supervises his/her care, to accompany the patient to study visits and to
             participate in the study

          -  No change to Alzheimer's disease (AD) medications within the month preceding
             randomization, including starting, stopping, or dosage modifications

        Exclusion criteria

          -  Meets criteria for Major Depressive Episode by Diagnostic and Statistical Manual of
             Mental Disorders, 4th edition, text revision (DSM-IV (TR)) criteria

          -  Presence of a brain disease that might otherwise explain the presence of dementia,
             such as extensive brain vascular disease, Parkinson's disease, dementia with Lewy
             bodies, traumatic brain injury, or multiple sclerosis

          -  Psychosis (delusions or hallucinations) requiring antipsychotic treatment in the
             opinion of the study physician

          -  Prolonged measure of the time between the start of the Q wave and the end of the T
             wave in the heart's electrical cycle (QT interval)

          -  Treatment with citalopram is contraindicated in the opinion of the study physician

          -  Failure of past treatment with citalopram for agitation after adequate trial at a
             minimally accepted dose (greater than or equal to 20 mg/day)

          -  Treatment with a medication that would prohibit the safe concurrent use of citalopram,
             such as Monoamine oxidases (MAO) inhibitors

          -  Need for psychiatric hospitalization or suicidal

          -  Current participation in a clinical trial or in any study that may add a significant
             burden or affect neuropsychological or other study outcomes

          -  Current treatment with antipsychotics, anticonvulsants (other than dilantin), other
             antidepressants (other than trazodone, less than or equal to 50 mg per day at
             bedtime), benzodiazepines (other than lorazepam), or psychostimulants

          -  Any condition that, in the opinion of the study physician, makes it medically
             inappropriate or risky for the patient to enroll in the trial