Dettagli per singolo studio

DEC-NET Serial number GB257

Published online	29/06/2004 12.49.00
Last updated	22/11/2005 9.58.30

Other protocol ID number	N0258107382
This trial has been approved by an ethics committee
Current trial status	Terminated (withdrawn)
First subject enrolment Target N. of subjects	10/2001 15
Major Disease (ICD9 class)	DEPRESSIVE DISORDER NOT ELSEWHERE CLASSIFIED
Experimental drug
Citalopram Treatment regimen (dosage and duration) Not available
Gender	Both
Age (range)	2 -18 years
Eligibility criteria
Inclusion criteria
Paediatric cancer patients with depression Informed consent given by parents and assent and/or informed consent where appropriate by child
Exclusion criteria
Children who refuse to follow studys protocol
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Quality of Life Assessment
Purpose of study
To explore the effectiveness of citalopram in treating symptoms of anxiety and depression in children and adolescents with cancer.
Primary outcomes
If this pilot study is able to demonstrate a significant benefit for paediatric cancer patients in treating their depressive symptoms with citalopram this would justify a larger mulit-centred controlled trial.


Summary of study design, objectives, and ongoing research findings
Quality of Life assessment. To explore the effectiveness of citalopram in treating symptoms of anxiety and depression in children and adolescents with cancer. If this pilot study is able to demonstrate a significant benefit for paediatric cancer patients in treating their depressive symptoms with citalopram this would justify a larger mulit-centred controlled trial. Please note this study was not completed due to difficulties in obtaining an adequate sample size. Analysis of the five cases showed an excellent response to treatment.