| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Generalised anxiety disorder |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10018075 |
| E.1.2 | Term | Generalised anxiety disorder |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
• To determine whether chronic (3 week) venlafaxine dosing reduces the anxiety symptoms induced by breathing a mixture of air and 7.5% carbon dioxide (CO2).
• To determine whether chronic (3 week) pregabalin dosing reduces the anxiety symptoms induced by breathing a mixture of air and 7.5% CO2.
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| E.2.2 | Secondary objectives of the trial |
• To determine whether chronic (3 week) venlafaxine dosing reduces the anxiety symptoms induced by breathing a mixture of air and 35% CO2.
• To determine whether chronic (3 week) pregabalin dosing reduces the anxiety symptoms induced by breathing a mixture of air and 35% CO2.
• To assess the influence of venlafaxine on CO2-induced changes in blood pressure and heart rate.
• To assess the influence of pregabalin on CO2-induced changes in blood pressure and heart rate.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Male or female aged 20 to 45 years, inclusive at randomisation (visit 2).
• Female participants should be surgically sterile or abstinent or, if sexually active, be practising an effective method of birth control (such as prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; they should have a negative urine pregnancy test at screening (visit 1) and randomisation (visit 2).
• Acceptable weight as defined by a body mass index (BMI: weight [kg]/height [m] ²) of 18 to 30 kg/m², inclusive.
• Normotensive with sitting (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive. A participant with blood pressure outside this range may be included only if the study physician judges that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Healthy on the basis of a pre-study physical examination, medical history, electrocardiogram, urinalysis dipstick and the laboratory results of blood haematology and biochemistry performed within 6 weeks before randomisation. If the results of haematology or biochemistry testing are not within the laboratory’s reference ranges the participant can be included only if the study physician judges that the deviations are not clinically significant. This should be clearly recorded in the source documents.
• Non-smoker or light smoker (<5 cigarettes per day).
• Willing to follow the prohibitions and restrictions as specified in Section 7, Prohibitions and Restrictions.
• Participant must have signed the informed consent form prior to the first study-related procedure, indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Those participants willing to participate in the pharmacogenomic components of the study must have confirmed they understand the purpose of the procedures involved and indicated that they are willing to participate by signing the appropriate informed consent form..
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| E.4 | Principal exclusion criteria |
• Known or suspected hypersensitivity or intolerance to venlafaxine/pregabalin or any of their excipients.
• History of alcohol or substance dependence within the last 6 months. Participants must have negative results at screening and at randomisation visit for the urine drug screen and alcohol breath test.
• Consumption of large amounts of caffeinated drinks (no more than 8 cups of standard caffeinated drinks (tea, instant coffee) or 6 cups of stronger coffee or other drinks containing methlyxantines such as coca cola or Red Bull per day).
• Relevant history or presence upon clinical examination, of cardiac, ophthalmologic, gastro-intestinal, hepatic, or renal disease or other condition known to increase risk of side effects of venlafaxine or pregabalin.
• Have a history or presence of neurological or psychiatric conditions (such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, schizophrenia, major depression, generalised anxiety disorder or panic disorder).
• History of, or current condition of, migraine headaches.
• Have received prescribed medication within 14 days prior to randomisation (apart from the contraceptive pill). Participants who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (refer to Section 8, Concomitant Therapy).
• Have received over-the-counter (OTC) medicine within 48 hours prior to randomisation (apart from paracetamol). Participants who have taken OTC medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (refer to Section 8, Concomitant Therapy).
• Participated in a trial with any drug within 84 days of randomisation (visit 2).
• If female: are pregnant or are trying to get pregnant or are currently breast feeding.
• Have a personal or a close family member with a history of panic attacks or severe anxiety disorder.
• History of claustrophobia.
• Previous experience of the CO2 procedure within the preceding six months.
• Current or clinically significant history of asthma.
• Unable or unwilling to comply with study procedures.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
- reduction in anxiety symptoms
The Anxiety Sensitivity Index (Reiss-Epstein-Gursky)
The Spielberger Trait Anxiety Inventory
The Spielberger State Anxiety Inventory
The GAD Criteria Inventory (GAD-C)
Visual Analogue Scales
The Panic Symptom Inventory
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
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