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NCT00715377
Anticholinergic Burden in Schizophrenia
NA trial testing Benztropine in Schizophrenia in 2 participants. Terminated before completion.
1 December 2011
Quick facts
| Lead sponsor | Centre for Addiction and Mental Health |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 1 June 2007 |
| Primary completion | 1 December 2011 |
| Estimated completion | 1 December 2011 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Benztropine — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
- Schizophreniform Disorder — all drugs for Schizophreniform Disorder →
- Delusional Disorder — all drugs for Delusional Disorder →
Sponsor
Centre for Addiction and Mental Health — full company profile →
Who can join
50 and older, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
percentage of participants who successfully withdraw from anticholinergic antiparkinsonian agents.
Time frame: at the end of the study
Sponsor's own description
Anticholinergic antiparkinsonian agents often cause side-effects including cognitive impairment, dry mouth, and constipation while they diminish antipsychotic-induced parkinsonian symptoms. The introduction of second generation antipsychotics (SGA) brought fewer neurological side effects. However, anticholinergic coprescription rates are still as high as 12-65% in patients on SGA that are much higher than the incidence of EPS reported in clinical trials (3-20%). This apparently discrepancy is likely explained, in part, by the established tradition of routine use of this medications. Older patients are particularly sensitive to anticholinergic side-effects due to age-related changes in pharmacokinetics and pharmacodynamics. In this study, we will examine the safety and benefits of reducing the dose of a frequently prescribed anticholinergics, benztropine, on cognitive function, extrapyramidal symptoms, and psychotic symptoms in older subjects with a primary psychotic disorder.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00715377
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Centre for Addiction and Mental Health trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00715377 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre for Addiction and Mental Health
- Last refreshed: 21 August 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00715377.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing