Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/08/2006
Date assigned
13/09/2006
Last edited
26/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17570858

Publication citations

  1. 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.

Additional files

Editorial Notes