Contact information
Type
Scientific
Primary contact
Prof Kristian Wahlbeck
ORCID ID
Contact details
Psychiatric unit
Vaasa Central Hospital
Vaasa
FIN-65130
Finland
kristian.wahlbeck@stakes.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We hypothesised that paroxetine will have a beneficial effect on quality of life and on glycaemic control in mildly depressed diabetics.
Ethics approval
Helsinki University Central Hospital ethics review committee has approved the study in 2001
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type two diabetes mellitus and depression.
Intervention
Paroxetin 20 mg per day or placebo for six months. Blood samples and clinical examination four times during the trial.
Intervention type
Drug
Phase
Not Specified
Drug names
Paroxetine
Primary outcome measure
10% decrease in HbA1c.
Secondary outcome measures
20% improvement in quality of life as defined by the RAND-36 health relate quality of life questionnaire.
Overall trial start date
01/06/2001
Overall trial end date
20/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Volunteers between 50 and 70 years of age
2. Diagnosed type two diabetes
3. Hba1c more than 7.0%
4. Mild symptoms of depression
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
38
Participant exclusion criteria
1. Moderate to severe depression based on Diagnostic and Statistical Manual of mental disorders (DSM-IV) criteria
2. Severe diabetic complications
3. Use of warfarin
4. Glaucoma
Recruitment start date
01/06/2001
Recruitment end date
20/12/2002
Locations
Countries of recruitment
Finland
Trial participating centre
Psychiatric unit
Vaasa
FIN-65130
Finland
Sponsor information
Organisation
GlaxoSmithKline (Finland)
Sponsor details
Piispansilta 9 A
3 krs.
Espoo
Helsinki
02230
Finland
terese.m.pfister-peltola@sb.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Funded by GlaxoSmithKline
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Paile-Hyvärinen M, Wahlbeck K, Eriksson JG, Quality of life and metabolic status in mildly depressed patients with type 2 diabetes treated with paroxetine: a double-blind randomised placebo controlled 6-month trial., BMC Fam Pract, 2007, 8, 34, doi: 10.1186/1471-2296-8-34.