Treatment of Generalized Anxiety Disorder comorbid with Major Depressive Disorder.

Phase 1

Conditions: Generalized Anxiety Disorder comorbid with major depressive disorder.
Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

Registration Number: EUCTR2012-004062-17-GR

Lead Sponsor: Aristotle University of Thessaloniki

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Generalized Anxiety Disorder (GAD) according to DSM-IV-TR diagnostic criteria
2. Major Depressive episode (MD) according to DSM-IV-TR diagnostic criteria
3. Patients already receiving esitalopram.
4. Male or female patients, aged between 18-65 years of age
5. Signed and dated patients’ informed consent received from patients who are able to understand and comply with study requirements.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any other comorbid condition
2. Abuse of alcohol or other substances at screening (excepting dependence being in total remission; excepting dependence on caffeine or nicotine), according to DSM-IV criteria
3. Abuse of substances such as opiates, amphetamines, barbiturates, cocaine, cannabis, hallucinogens for a duration of four weeks before screening day, according to DSM-IV criteria
4. Any DSM-IV-TR-defined psychic disorder that may affect the interpretation of results
5. Female patients of reproductive age who do not apply any reliable contraceptive method and do not have a negative human chorionic gonadotropin (HCG) value at screening
6. Patients who are in severe danger of suicide, or represent a danger to themselves and others in the investigator’s judgment
7. Known hypersensitivity or lack of responsiveness to the trial drugs in the investigator’s judgment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test whether pregabalin versus placebo as adjunctive treatment on open-label escitalopram will result in a greater reduction of anxiety symptoms, and simultaneously in better mental speed.;Secondary Objective: 1. To test whether depression symptoms respond better to the combination of pregabaline plus escitalopram, compared with escitalopram plus placebo.<br>2. To assess the functioning of the Autonomic Nervous System (ANS) with the use of pupillometry.<br>3. To test mental speed at a more superficial level, i.e. with an easier task. ;Primary end point(s): Changes in the anxiety scale State-Trait Inventory form Y, STATE (STAI-S) and in the Trail Making Test – form B.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in the Center of Epidemiological Studies-Depression (CES-D) scale score;<br>change in the Trail Making Test – form A;<br>pupillometry: absolute pupil size at baseline;<br>pupillometry: absolute pupil size at maximum constriction after single flash at 1 Hz;<br>pupillometry: % of pupil size change after single flash at 1 Hz;<br>pupillometry: absolute pupil size after a series of ten flashes at 1 Hz;<br>pupillometry: % of pupil size change after a series of ten flashes at 1 Hz;<br>pupillometry: ratio of pupil size change after single flash at 1 Hz, compared with pupil size change after a series of ten flashes at 1 Hz.<br>Evaluation of possible adverse events with the use of the UKU scale.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study.