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Comparing the effect of Antipsychotic drugs with or without Cobalamin in elimination of pain and symptoms of psychosis in Alzheimer's patients

Comparing the effect of Quetiapine and Risperidone with or without Cobalamin in elimination of pain and symptoms of psychosis in Alzheimer's patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201501101061N18
Enrollment
80
Registered
2016-05-15
Start date
2015-01-19
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Alzheimer disease. Alzheimer disease

Interventions

Intervention 1: one group of Patients is treated randomly with quetiapine alone, 12.5 mgr in night and rise to 25 to 50 mg according to patient condition. Intervention 2: one group of Patients is trea
Treatment - Drugs
one group of Patients is treated randomly with quetiapine alone, 12.5 mgr in night and rise to 25 to 50 mg according to patient condition
one group of Patients is treated randomly with Risperidone alone, 0.5 mgr in night and rise to 1 to 2 mg daily according to patient condition
one group of Patients randomly received Quetiapine 12.5 mg or higher dose ,combined with a monthly 1000 mcgr. vitamin B12
one group of patients randomly received Risperidone 0.5 mg or higher dose combined with 1000 mcgr vitamin B12 per month

Sponsors

Rafsanjan University of Medical Siences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: Alzheimer diagnosis in elderly patients is carried out on basis of clinical interviews; DSM IV diagnosis criteria; medical history; clinical examinations; MRI and brain CT scan results and the mini mental state examination score; Patients who have mini mental score above than are studied; patient with Brief Psychiatric Rating Scale score 30-70. Exclusion criteria Patients who were taking anti-psychotic medication; has schizophrenia symptoms; preliminary psychotic disorders; delirium; psychoses followed by drug or medication take; Other medical background disorders like B12 deficiency and hypothyroidism; Patients needed to be hospitalized; Patients posed to suicide commitment risk; Other causes of dementia like brain tumors; strokes; normal pressure hydrocephalus; Underlying medical conditions; that may cause behavioral or psychotic symptoms or delirium such as infection, medications with anticholinergic effects; corticosteroid use; or neurological insults is the first step in the decision-making process for treatment. In addition, the patients were discarded from the procedure if they need further medical intervention and other drugs according to their health status or families’ remark

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: before treatment , 2 weeks and 8 weeks after treatment. Method of measurement: Visual Analogue Scale for pain Questionnaire.;Psychiatric symptoms. Timepoint: before treatment , 2 weeks and 8 weeks after treatment. Method of measurement: Breif Psychiatric Rating Scale Questionnaire.

Secondary

MeasureTime frame
Patient progress and treatment response. Timepoint: 2 weeks and 8 weeks after treatment. Method of measurement: Clinical Global Impressions scale Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public Contact?Alireza Vakilian

Rafsanjan University Of Medical Sciences

alirezavakilian66@rums.ac.ir+98 34 3425 5900

Outcome results

None listed

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