Condition category
Mental and Behavioural Disorders
Date applied
17/09/2003
Date assigned
19/09/2003
Last edited
27/09/2011
Prospective/Retrospective
Prospectively 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

Mr Glyn Lewis

ORCID ID

Contact details

Division of Psychiatry
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
+44 0117 954 6796
Glyn.lewis@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0200243

Study information

Scientific title

Acronym

GENPOD

Study hypothesis

We wish to identify genetic and clinical predictors of response to SSRIs and NaRIs in depressive illness. Hypotheses:
1. Those who are homozygous for the insertion allele polymorphism in the promoter region of the 5HT transporter who are allocated SSRIs will have an improved response compared to those on NaRIs. This also implies that those who are not homozygous will have reduced response on SSRIs compared to those on NaRIs.
2. Those who have more severe depressive disorders who are allocated NaRIs and less severe disorder allocated SSRIs will have a better response compared to the other two groups

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders

Intervention

1. Reboxetine 4mg bd
2. Paroxetine 20mg

Intervention type

Drug

Phase

Not Specified

Drug names

Reboxetine, Paroxetine

Primary outcome measures

Beck depression inventory total score (BDI) at 6 weeks adjusted for baseline BDI score.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

23/02/2004

Overall trial end date

22/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

18-74 years with the more severe depressions in whom the GP and patient have already agreed that antidepressants should be prescribed. We will therefore only include those with a Clinical Interview Schedule - Revised (CIS-R) score of ≥20, a Beck Depression Inventory (BDI) score of ≥15 and a diagnosis of International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10) depressive episode F32 and F33 (from CIS-R).

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

887
Added 18/08/09: recruitment ongoing

Participant exclusion criteria

Pregnant and breast feeding women, patients with psychotic illness, alchohol or substance abuse problems, patients with medical contraindications to Citalopram or Reboxetine. (June 2006: Exclusion criteria were provided as follows: Potential subjects who have taken antidepressant medication within 2 weeks, who cannot complete self-administered scales, who have a psychosis or major substance or alcohol abuse. The GP will exclude anyone who has medical contraindications or in whom participation in the trial is not appropriate.)

Recruitment start date

23/02/2004

Recruitment end date

22/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Psychiatry
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7670 5259
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (G0200243) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18498636
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21263010

Publication citations

  1. Protocol

    Thomas L, Mulligan J, Mason V, Tallon D, Wiles N, Cowen P, Nutt D, O'Donovan M, Sharp D, Peters T, Lewis G, GENetic and clinical predictors of treatment response in depression: the GenPod randomised trial protocol., Trials, 2008, 9, 29, doi: 10.1186/1745-6215-9-29.

  2. Results

    Lewis G, Mulligan J, Wiles N, Cowen P, Craddock N, Ikeda M, Grozeva D, Mason V, Nutt D, Sharp D, Tallon D, Thomas L, O'Donovan MC, Peters TJ, Polymorphism of the 5-HT transporter and response to antidepressants: randomised controlled trial., Br J Psychiatry, 2011, 198, 6, 464-471, doi: 10.1192/bjp.bp.110.082727.

Additional files

Editorial Notes