Tariot PN, Jakimovich LJ, Erb R, et al. Withdrawal from controlled carbamazepine therapy followed by further carbamazepine treatment in patients with dementia. Journal of Clinical Psychiatry 1999;60:684-89
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/9433339
| Methods | Study design: Randomized blind placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 51 randomized, 45 completed
· Active deprescribing group: 27 randomized, 22 completed the wash-out phase · Control group: 24 randomized, 23 completed deprescribing phase Age: 86 ± 6.4 years Sex: Not described Participants with dementia: All, MMSE: 6 ± 7 · Alzheimer’s disease by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association criteria, n=33 · Vascular dementia DSM-IV criteria, n=13 · Mixed dementias, n=5 Inclusion criteria · Dementia, diagnosed as: o criteria for probable or possible Alzheimer’s Disease of DSM-III-R and of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association o DSM-III-R criteria for vascular dementia, or o DSM-III-R criteria for mixed dementias · 60 years old or older · Exhibited agitation for at least 2 weeks and with sufficient intensity to result in a Brief Psychiatric Rating Scale score of three or higher on the tension, hostility, uncooperativeness, or excitement item · Free of acute illness as reflected by medical history examination, and laboratory testing · Designated family member to assist in the consent process Exclusion criteria: · Too agitated to tolerate protocol · Required treatment with other medications not permitted by protocol · Unable to comply with venepuncture or oral medication · Primary physician did not agree · Already receiving carbamazepine · Lack of family member to provide consent Concomitant medicines: No psychotropic other than chloral hydrate were permitted or used Country: United States of America Setting: Community – four long-term care facilities in Rochester, N.Y., that ranged from 350 to 600 beds. Prospective subjects were referred by their multidisciplinary care teams |
| Interventions | Medicine: Carbamazepine
Withdrawal schedule: Not described Comparator: Deprescribing placebo |
| Outcomes | Brief Psychiatric Rating Scale
Physical Self-Maintenance Scale Clinical Global Impressions scale MMSE Adverse effects |
| Dates | Dates: Not described
Follow-up duration: 24 weeks total. Eight weeks of blinded treatment, followed by three weeks deprescribing, and then 12 weeks open treatment. |
| Funding sources | “Supported by grants from the National Institute on Aging to the Rochester Area Pepper Center (AG 10463) and the Rochester Alzheimer’s Disease Core Center (AG 08665) and by Monroe Community Hospital. Carbamazepine and placebo were donated by Ciba-Geigy Corporation, Summit, N.J.” |
| Notes | *Data taken from the end of the wash-out period, not from the period after the medicine was re-administered. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | The method is not defined.
“6-week, randomized, multisite, parallel-group study of placebo versus optimal doses of carbamazepine. The randomization was blocked by site.” |
| Allocation concealment (selection bias) | High risk | The deprescribing phase was not blinded. |
| Blinding of participants and personnel (performance bias) | High risk | The deprescribing phase was not blinded. “to investigate whether clinical benefits observed with carbamazepine therapy in the initial 6-week phase of the study would diminish significantly during wash-out as assessed by raters blinded to the original treatment condition.” |
| Blinding of outcome assessment (detection bias) | Low risk | “after the initial 6-week blinded phase, experimental therapy was stopped for 3 weeks (“wash-out”), at the end of which (week 9) ratings were performed by clinicians who had performed the ratings in the placebo-controlled phase and remained blinded to the original treatment condition.” |
| Incomplete outcome data (attrition bias) | High risk | As-treated analysis. |
| Selective reporting (reporting bias) | High risk | Significant deviation.
“The design was changed for administrative reasons after several subjects were enrolled when we received funding to perform a larger, simpler, parallel-group study.” |
| Other bias | Low risk |
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