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The University of Southampton
Centre for Clinical and Experimental PsychopharmacologyGAD Research

Pregabalin Augmentation

Using pregabalin to augment antidepressant treatments.

What is the aim of the research?

When patients don’t respond to initial treatment (usually with SSRIs or SNRIs) there are several different possibilities in patient management. Some doctors recommend an increase in daily dosage, some combine the medication with a psychological treatment (e.g. CBT) and others switch to a different treatment entirely. One option is to ‘augment’ the treatment with an additional drug, such as pregabalin. Recent research (Rickels et al. 2012) has shown that pregabalin has positive effects when augmenting SSRI or SNRI treatments in patients with anxiety disorders, compared to a placebo control. We hope to use computer tasks to find out why pregabalin has these potentially helpful effects, which will help us to improve augmentation treatments.

Can I take part in the research?

You can apply to take part in the research if you are aged between 18-70, have been diagnosed with GAD and have been being treated with SSRIs or SNRIs for at least 6 weeks. If you fit this criteria, and would like to find out more, please complete the form below and we will contact you regarding eligibility.

What will I have to do if I am eligible?

The study has three phases: retrospective, prospective (6 weeks) and augmentation (6 weeks). In the retrospective phase, we will examine previous treatment with either SSRI or SNRI antidepressants to confirm your eligibility for the study. In the prospective phase, we will deliver subsequent treatment with an SSRI or SNRI at our clinic in College Keep. In patients who do not respond fully to treatment during the prospective phase will enter the augmentation phase, in which their existing treatment is augmented with pregabalin.
During the retrospective phase you won’t need to do anything different to your usual treatment, but if you are eligible for the study you will need to come into the clinic at the start of the prospective phase (and then after weeks 2, 4 and 6). In the augmentation phase, you will need to complete some brief computer tasks at the beginning and end, as well as coming into the clinic after weeks 1, 2, 4 and 6.

Will there be any risk to me as a participant?

There are no additional risks during this study beyond those associated with prescribing antidepressants and pregabalin to patients with GAD. Pregabalin has been approved for treating anxiety disorders in the EU and Russia, and is a current treatment for a number of other disorder such as fibromyalgia. The regular clinic visits and detailed assessment of treatment effectiveness are likely to benefit you, compared to results from standard clinical care.
Throughout the experiment you will be closely monitored for your response to antidepressant and pregabalin treatment, and should you respond to treatment, you should have no difficulty continuing with the relevant medication as all treatments delivered in the study are widely available. Any data about you will be confidential, you will be free to withdraw from the study at any time (without giving a reason) and your decision to do so will not affect any standard of continuing care you would receive.

How do I get more information? (contact details)

If you are interested in taking part in this study, please complete the contact form below and you will be contacted by someone from our research team. If you are not sure whether you are eligible for the study, but still want to take part, have a look at our ‘diagnostic criteria’ page. If you are still not sure, let us know through the contact form and we will contact you to confirm.

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