A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002482-20-GB

Enrollment

Registered

2005-02-15

Start date

2005-12-02

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptoms of Depression as defined by the Hospital Anxiety and Depression Questionnaire associated with Rheumatoid Arthritis

Interventions

Trade Name: Efexor XL 75 mg Product Name: Efexor XL 75 mg (venlafaxine) Product Code: NA Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: Venlafaxine Hydrochloride Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Rheumatoid Arthritis(ACR criteria) Male or Female Aged 18 years or over. Female patients of childbearing potential must be using an adequate and reliable method of contraception whilst taking Venlaflaxine. Willing and able to provide written informed consent. Functional classification of II or III (ACR criteria) A score > 10 on the Hospital anxiety and Depression score Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previously Diagnosed Depression Other physically disabling condition/concomitant chronic disease Contraindicated use of Venlaflaxine

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects of Venlaflaxine in a rheumatoid population who have evidence of symptoms of depression;Secondary Objective: To observe the effect treating depression has on an individuals physical activity as measured with a 24 hour ambulatory activity monitor;Primary end point(s): Depression is very common in RA, yet assessment and treatment is not routine practice. In a recent survey in our department, depression, as indicated by the HAD >8 score, was found in 45% of 123 participants, with 25% (HAD >10) categorised as either moderately or severely depressed. Primary treatment of RA is aimed at reducing inflammation and improving function. Part of this function is ambulation which can be objectively measured using a specifically designed monitor, the NUMACT. Reduced physical function is also considered to be a feature of depression and therefore it is anticipated that an improvement in mental health may also contribute to improved physical function. This is an intervention study using a licensed antidepressant treatment (Venlaflaxine) in patients with diagnosed rheumatoid arthritis. The aim is to observe changes in mental state as defined by the HAD score and physical activity as measured by the Numact ambulatory activity monitor. The secondary aim is to observe changes in self-report disability (HAQ), depression and anxiety (HAD), pain and fatigue (VAS P/F) scores and a multi-dimensional health status questionnaire (SF36). HAQ - Health Assessment Questionnaire (Fries, et al 1980) HAD - Hospital Anxiety and Depression (Zigmond & Snaith, 1983) VAS P/F - Visual analogue scale Pain / Fatigue (McCormack et al 1988) SF36 - Short Form 36 This is an open, observational PILOT study of 20 patients with diagnosed rheumatoid arthritis who are indicating symptoms of depression; and therefore no sample size has been calculated. It is an un-controlled, open label pilot study to test the effect of treating depression asso	—

Measure

Time frame

Main Objective: To assess the effects of Venlaflaxine in a rheumatoid population who have evidence of symptoms of depression;Secondary Objective: To observe the effect treating depression has on an individuals physical activity as measured with a 24 hour ambulatory activity monitor;Primary end point(s): Depression is very common in RA, yet assessment and treatment is not routine practice. In a recent survey in our department, depression, as indicated by the HAD >8 score, was found in 45% of 123 participants, with 25% (HAD >10) categorised as either moderately or severely depressed. Primary treatment of RA is aimed at reducing inflammation and improving function. Part of this function is ambulation which can be objectively measured using a specifically designed monitor, the NUMACT. Reduced physical function is also considered to be a feature of depression and therefore it is anticipated that an improvement in mental health may also contribute to improved physical function. This is an intervention study using a licensed antidepressant treatment (Venlaflaxine) in patients with diagnosed rheumatoid arthritis. The aim is to observe changes in mental state as defined by the HAD score and physical activity as measured by the Numact ambulatory activity monitor. The secondary aim is to observe changes in self-report disability (HAQ), depression and anxiety (HAD), pain and fatigue (VAS P/F) scores and a multi-dimensional health status questionnaire (SF36). HAQ - Health Assessment Questionnaire (Fries, et al 1980) HAD - Hospital Anxiety and Depression (Zigmond & Snaith, 1983) VAS P/F - Visual analogue scale Pain / Fatigue (McCormack et al 1988) SF36 - Short Form 36 This is an open, observational PILOT study of 20 patients with diagnosed rheumatoid arthritis who are indicating symptoms of depression; and therefore no sample size has been calculated. It is an un-controlled, open label pilot study to test the effect of treating depression asso

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026