Study of mirtazapine for agitation in dementia

Phase 3

Completed

• Conditions: Agitation and/or aggression in people with dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN17411897
• Lead Sponsor: niversity of Sussex

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34688369/ (added 26/10/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37929672/ (added 06/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-28
• Study Completion: 2020-06-30
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

1. Aged 18 years and over
2. Clinical diagnosis of probable or possible Alzheimer’s Disease using National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria
3. A diagnosis of co-existing agitated behaviours
4. Evidence that the agitated behaviours have not responded to management according to the AS/DH algorithm
5. If receiving cholinesterase inhibitors or memantine, must be on a stable dose (defined as three months on current dose)
6. A Cohen Mansfield Agitation Inventory score of 45 or greater
7. Written informed consent to enter and be randomised into the trial or consultee agreement for those without capacity
8. Availability of a suitable informant (consenting identifiable family carer or paid carer) to provide information on carer-completed outcome measures and who consents to take part in the trial

Exclusion Criteria

Current exclusion criteria as of 28/01/2019:
1. Current treatment with antidepressants (including monoamine oxidase inhibitors (MAOIs)), anticonvulsants, antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration
2. Contraindications to the administration of mirtazapine as per its current SmPCs
3. Patients with atrioventricular block, a history of bone marrow depression or history of hepatic porphyrias
4. Cases too critical for randomisation (ie where there is a suicide risk or where the patient presents a risk of harm to others)
5. Female subjects under the age of 55 of childbearing potential, defined as follows: postmenopausal females who have not had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have not had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment

Previous exclusion criteria:
1. Current treatment with antidepressants (including monoamine oxidase inhibitors (MAOIs)), anticonvulsants, antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration
2. Contraindications to the administration of carbamazepine and mirtazapine as per their current SmPCs
3. Patients with atrioventricular block, a history of bone marrow depression or history of hepatic porphyrias
4. Cases too critical for randomisation (ie where there is a suicide risk or where the patient presents a risk of harm to others)
5. Female subjects under the age of 55 of childbearing potential, defined as follows: postmenopausal females who have not had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have not had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment

Study & Design

• Study Type: Interventional
• Study Design: Not specified