Effect of paroxetine treatment on glycaemic control and quality of life in mildly depressed type two diabetic subjects: a double-blind randomised placebo controlled six month trial

ISRCTN ISRCTN55819922
DOI https://doi.org/10.1186/ISRCTN55819922
Secondary identifying numbers N/A
Submission date
02/08/2006
Registration date
13/09/2006
Last edited
26/06/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kristian Wahlbeck
Scientific

Psychiatric unit
Vaasa Central Hospital
Vaasa
FIN-65130
Finland

Email kristian.wahlbeck@stakes.fi

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWe hypothesised that paroxetine will have a beneficial effect on quality of life and on glycaemic control in mildly depressed diabetics.
Ethics approval(s)Helsinki University Central Hospital ethics review committee has approved the study in 2001
Health condition(s) or problem(s) studiedType two diabetes mellitus and depression.
InterventionParoxetin 20 mg per day or placebo for six months. Blood samples and clinical examination four times during the trial.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Paroxetine
Primary outcome measure10% decrease in HbA1c.
Secondary outcome measures20% improvement in quality of life as defined by the RAND-36 health relate quality of life questionnaire.
Overall study start date01/06/2001
Completion date20/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants38
Key inclusion criteria1. Volunteers between 50 and 70 years of age
2. Diagnosed type two diabetes
3. Hba1c more than 7.0%
4. Mild symptoms of depression
Key exclusion criteria1. 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
Date of first enrolment01/06/2001
Date of final enrolment20/12/2002

Locations

Countries of recruitment

  • Finland

Study participating centre

Psychiatric unit
Vaasa
FIN-65130
Finland

Sponsor information

GlaxoSmithKline (Finland)
Industry

Piispansilta 9 A
3 krs.
Espoo
Helsinki
02230
Finland

Email terese.m.pfister-peltola@sb.com
ROR logo "ROR" https://ror.org/01jxkq910

Funders

Funder type

Industry

Funded by GlaxoSmithKline

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 15/06/2007 Yes No