Skip to content
Clinical Trials – home

Generalised anxiety disorder Treatment

2 / 4 trials open to patients10 countries

In short

Generalised anxiety disorder (GAD) is a mental health condition where persistent worry becomes difficult to control and affects daily life. While it can feel overwhelming, there are proven treatments available, from talking therapies to medications, and research continues to explore new approaches to help people manage their symptoms and improve their quality of life.

Key points

  • Cognitive behavioral therapy is the most effective form of psychotherapy for GAD, teaching specific skills to manage worry and gradually face anxiety-provoking situations.
  • SSRIs and SNRIs are recommended as first-line medications and typically need to be continued for at least six to twelve months after symptoms improve to prevent relapse.
  • Around half of people don't respond adequately to their first treatment attempt, making treatment-resistant GAD a common challenge that requires alternative strategies.
  • Benzodiazepines are not recommended for first-line or long-term treatment due to risks of dependence and other serious side effects.
  • Combining psychotherapy with medication often produces better outcomes than either treatment alone.
  • GABA-related medications and atypical antipsychotics are being studied in clinical trials as potential add-on treatments for people whose anxiety doesn't respond to standard approaches.
  • Lifestyle changes including regular exercise, adequate sleep, healthy eating, and limiting caffeine can complement formal treatments and help reduce anxiety symptoms.
  • Only about 43% of people with GAD currently receive treatment, despite highly effective therapies being available.

What treatment aims to achieve in generalised anxiety disorder

The goal of treating generalised anxiety disorder is not simply to eliminate all worry from a person's life, but rather to bring anxiety down to a manageable level. Treatment focuses on helping people regain control over their thoughts and feelings so they can function well at work, at home, and in social situations. For many people, the condition can be a long-term challenge, but with proper support, symptoms can improve significantly.

Treatment approaches depend on how severely the anxiety is affecting someone's ability to carry out everyday activities. Some people find their symptoms interfere only mildly with their routine, while others struggle to get through each day. Medical professionals assess the severity and duration of symptoms before recommending a treatment plan. It's important to remember that what works for one person may not work for another, so finding the right approach often involves some trial and adjustment.

Standard treatments for GAD have been developed and approved by medical societies over many years of clinical experience. At the same time, researchers continue to investigate new therapies through clinical trials, searching for approaches that might work better or have fewer side effects. The treatment landscape for anxiety disorders is evolving, with both established methods and promising experimental options available to patients at different stages of their journey.

Established treatments used in clinical practice

Psychological therapies for anxiety

Psychotherapy, also known as talk therapy or psychological counseling, is one of the most effective treatments for generalised anxiety disorder. It involves working with a trained therapist to understand and manage anxiety symptoms. The most researched and effective form of psychotherapy for GAD is cognitive behavioral therapy, or CBT for short.

Cognitive behavioral therapy has two main components. The cognitive part focuses on identifying and changing thought patterns that trigger or worsen anxiety. People with GAD often perceive situations as threatening even when they aren't, and CBT helps them recognize these distorted thoughts. The behavioral part involves gradually facing feared situations rather than avoiding them. Through repeated exposure to anxiety-provoking scenarios in a controlled way, people learn that their feared outcomes rarely happen, and their anxiety naturally decreases over time.

CBT is typically offered as weekly sessions over several weeks or months. In some cases, these sessions can be conducted virtually through video calls, making treatment more accessible. The therapy teaches specific skills that people can use to directly manage their worries. As patients practice these techniques and see improvement, they gradually return to activities they had been avoiding because of anxiety. The benefits of CBT extend beyond just reducing anxiety—it can also help with symptoms of depression, which often accompany GAD.

It's worth noting that CBT involves directly confronting fears, which can be distressing during the therapy process itself. Some people find the exercises challenging or uncomfortable at first. However, therapists guide patients through this process carefully, starting with less anxiety-provoking situations and building up gradually.

Combining treatments for better results

Many people benefit most from a combination of psychotherapy and medication. Research shows that both approaches can be effective on their own, but using them together often produces better outcomes than either treatment alone. The medication can help reduce symptoms enough that the person can engage more effectively in therapy, while therapy provides skills and strategies that continue to help even after medication is stopped.

Healthcare providers usually recommend trying talking therapies before prescribing medication, or alongside it from the beginning. The choice depends on the severity of symptoms, the person's preferences, and whether they've tried treatments before. Some people prefer to avoid medication if possible, while others find that medication gives them the stability they need to participate in therapy.

Innovative approaches being studied in clinical trials

When standard treatments don't work well enough

Around half of the people treated for generalised anxiety disorder don't respond adequately to their first treatment attempt. When someone has tried at least one antidepressant at an appropriate dose for an appropriate length of time and still has significant symptoms, doctors describe this as treatment-resistant GAD. This situation is more common than many people realize, and it has led researchers to investigate alternative medication approaches and strategies to augment standard treatments.

Treatment-resistant doesn't mean untreatable. It simply means that additional or different strategies need to be explored. In these situations, doctors might try switching to a different medication, adding a second medication to boost the effects of the first, or combining medication with more intensive psychotherapy.

Medications affecting brain chemistry in new ways

Research into treatment-resistant GAD has identified several medication classes that show promise when added to standard antidepressants. One class that has generated considerable research interest is the GABA-related agents. GABA, which stands for gamma-aminobutyric acid, is a neurotransmitter that helps calm brain activity. People with anxiety disorders may have abnormalities in their GABA system.

Pregabalin is a medication that affects GABA activity in the brain. Originally developed for treating nerve pain and seizures, researchers found that it also reduces anxiety symptoms. Clinical trials have tested pregabalin as an additional treatment for people whose anxiety hasn't responded well to standard antidepressants. The medication appears to work relatively quickly, sometimes within a week or two, which is faster than typical antidepressants.

Another GABA-related medication studied in clinical trials is tiagabine, which increases GABA levels in the brain by preventing its breakdown. Early phase studies examined whether tiagabine could help reduce anxiety when added to existing treatments. However, research on this medication for anxiety is more limited compared to pregabalin.

Side effects of GABA-related medications can include dizziness, drowsiness, weight gain, and coordination problems. Researchers in clinical trials carefully monitor participants for these and other potential side effects to determine whether the benefits outweigh the risks.

Atypical antipsychotics as augmentation therapy

Atypical antipsychotics are another class of medications being investigated for treatment-resistant generalised anxiety disorder. These medications were originally developed to treat conditions like schizophrenia and bipolar disorder, but researchers have found that at lower doses, some of them might help reduce anxiety symptoms when standard treatments aren't working well enough.

These medications work by affecting multiple neurotransmitter systems in the brain, including dopamine and serotonin. The theory is that by modulating these chemical messengers in different ways than standard antidepressants, atypical antipsychotics might help people whose brain chemistry doesn't respond well to SSRIs or SNRIs alone. Clinical trials have tested several medications in this class as add-on treatments to ongoing antidepressant therapy.

The use of atypical antipsychotics for anxiety remains somewhat controversial because these medications can have significant side effects. These can include weight gain, metabolic changes affecting blood sugar and cholesterol, drowsiness, and movement problems. For this reason, they are typically considered only when other treatment options have been tried and found insufficient. Clinical trials carefully track both the benefits and potential harms to help determine which patients might benefit most from this approach.

Understanding what clinical trials measure

When researchers test potential treatments for GAD in clinical trials, they measure several things to determine whether a treatment is working. They track changes in symptom severity using standardized questionnaires that ask about worry, physical symptoms, and how much anxiety interferes with daily life. They also monitor side effects carefully, asking participants regularly about any new symptoms or problems they're experiencing.

Many clinical trials are conducted at major medical centers and universities, though some take place in community clinics as well. Trials may be specific to certain countries or regions, or they may be international studies. People interested in participating typically need to meet specific criteria—for example, having tried at least one standard treatment without adequate improvement, being within a certain age range, and not having certain other medical conditions that could interfere with the study.

Preliminary results from clinical trials can provide hope, but it's important to remember that not all promising early findings lead to approved treatments. A medication might show benefits in early trials but later prove to have unacceptable side effects or work no better than existing treatments when studied more thoroughly. The clinical trial process is designed to protect patients by carefully vetting new treatments before they become widely available.

Most common treatment methods

  • Cognitive behavioral therapy (CBT)
    • The most effective form of psychotherapy for generalised anxiety disorder, involving weekly sessions with a therapist over several weeks or months
    • Teaches specific skills to identify and change thought patterns that trigger anxiety and gradually face feared situations
    • Can be delivered in person, in groups, or through video calls for greater accessibility
    • Benefits extend beyond anxiety reduction and can help with accompanying depression symptoms
  • Antidepressant medications
    • Selective serotonin reuptake inhibitors (SSRIs) are recommended as first-line medication treatment for GAD
    • Serotonin-norepinephrine reuptake inhibitors (SNRIs) are also effective first-line options
    • These medications work by affecting neurotransmitters like serotonin and norepinephrine in the brain
    • Typically require several weeks before symptoms improve and should be continued for at least six to twelve months after response to reduce relapse
    • Common side effects include nausea, appetite changes, sleep disturbances, and sexual problems
  • GABA-related medications (for treatment-resistant cases)
    • Pregabalin affects GABA activity in the brain and has been studied as an add-on treatment when standard antidepressants don't work well enough
    • Works relatively quickly, sometimes within one to two weeks, faster than typical antidepressants
    • May cause side effects including dizziness, drowsiness, weight gain, and coordination problems
  • Atypical antipsychotics (for treatment-resistant cases)
    • Used at lower doses than for their original purpose, as add-on treatment when anxiety doesn't respond to standard medications
    • Work by affecting multiple neurotransmitter systems including dopamine and serotonin
    • Potential side effects include weight gain, metabolic changes, drowsiness, and movement problems
    • Typically considered only after other treatment options have been tried
  • Combination therapy
    • Many people benefit from using both psychotherapy and medication together
    • Medication can reduce symptoms enough to allow more effective participation in therapy
    • Therapy provides skills that continue to help even after medication is stopped
  • Lifestyle and self-help approaches
    • Regular physical activity such as running, walking, swimming, and yoga can reduce anxiety and stress symptoms and improve sleep
    • Relaxation techniques including calming breathing exercises can help manage anxiety symptoms
    • Getting enough sleep and eating a healthy diet with regular meals helps maintain stable energy levels
    • Avoiding excessive caffeine from coffee, tea, cola, or energy drinks can prevent worsening of anxiety symptoms

Did you know?

  1. Around half of all people treated for generalised anxiety disorder don't respond adequately to their first treatment attempt, which is why researchers continue searching for new approaches.
  2. Cognitive behavioral therapy can actually change how your brain functions over time, with brain imaging studies showing that successful CBT alters activity in areas of the brain involved in processing anxiety and fear.
  3. Although only about 43% of people with GAD are currently receiving treatment, the condition affects roughly 3% of adults at any given time—meaning millions of people worldwide are living with untreated anxiety.

Questions people often ask

This guide is here to help you understand the condition. It does not replace a conversation with your doctor, who knows your situation best.

Clinical trials for Generalised anxiety disorder

Recruiting trials first

See all 4 trials →
Quick filters

4 clinical trials in this condition

Countries:BulgariaBulgaria
  • Participants:18–64 years · 65+ years
  • Substances:Iti-1284
  • Sponsor:Intra-Cellular Therapies Inc.
Countries:BulgariaBulgaria
  • Participants:18–64 years · 65+ years
  • Substances:Iti-1284
  • Sponsor:Intra-Cellular Therapies Inc.
Countries:CzechiaCzechia
  • Participants:18–64 years · 65+ years
  • Substances:LYSERGIDE
  • Sponsor:Definium Therapeutics US Inc.
Countries:BulgariaBulgaria
  • Participants:18–64 years · 65+ years
  • Substances:Ulotaront
  • Sponsor:Otsuka Pharmaceutical Development & Commercialization Inc.
See all 4 trials →filters applied: condition = Generalised anxiety disorder

Related conditions in the same therapeutic area

Back to all diseases
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).