A multicenter, parallel-group, double-blind, randomized, placebo-controlled, increasing-dose study, to evaluate preliminarily the clinical effects, the safety and tolerability of ABIO 08/01, in patients suffering from panic disorder. - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

 Caucasian males between 18 and 60 years of age on the day of the screening visit.

 Patients affected by panic disorders (including naïve patients) according to DSM-IV, evaluated with SCID-P.

 PDSS (Panic Disease Severity Scale) total score > 12.

 Patients are required to have screening and baseline total scores of at least 20 on the Hamilton Rating Scale for Anxiety (HAM-A) and scores of at least 2 on items 1 (anxious mood) and 2 (tension). However, patients who had a reduction of at least 20% in the HAM-A total score between the screening visit and the baseline visit are not eligible.

 Willing and able to understand and sign an Informed Consent form.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

 History of alcohol or drug abuse in the last year.

 Positive toxicological urinary screening.

 Smokers of more than 20 cigarettes/day.

 History of allergic response to drugs.

 Participation to a previous clinical trial within the past 3 months.

 Patients with coexisting primary MDD, evaluated by means of HAM-D.

 History or presence of any psychotic illness, bipolar disorder, antisocial personality or other severe Axis II disorder, or if they had a clinically significant psychiatric disturbances other than panic disorders.

 Patients at immediate risk of committing harm to self or others.

 Use of any investigational drug or procedure, any antipsychotic, antiepileptic antihistaminic drug, or the regular use of benzodiazepines or hypnotics within 30 days from baseline; or any use of antidepressants (including TCAs) within 14 days (fluoxetine within 30 days) or any episodic use of an anxiolytic within 7 days before baseline visit.

 Electroconvulsive therapy in the year prior to entry.

 Treatment with any known enzyme inhibiting or inducing agents (barbiturates, phenothiazines, etc.) within the past 4 weeks.

 Patients with treatment resistant panic disorder (defined as lack of response to two different effective drugs both used over six weeks at therapeutic dosages).

 Positive to HIV test and/or Hepatitis B or C tests.

 Unwilling to give written informed consent.

 Drinking excessive amounts of tea, cacao, coffee and/or beverages containing caffeine (> 5 cups/day) or wine (> 0,5 l/day or equivalents for spirits).

 In the judgment of the Clinical Investigator subjects likely to be not compliant or uncooperative during the study.

 Lack of an appropriate family support.

 Patients with clinically significant diseases other than the disease under study. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the trial or the patient?s ability to participate in the study.

 Patients with a history of clinically significant liver disease (defined as SGOT or SGPT> 3 times UNL), renal disease (defined as a serum creatinine >2.0 mg/dl) or clinical history of major cardiovascular disease. Severe neurological disease which may impair the results. The only patients with known prior malignant disease who are eligible are those with cured skin cancer (excluding melanoma).

 Patients who do not wish to discontinue current, ineffective treatment for panic disorder.

 Patients who have undergone psychotherapy during the previous 6 months from the study entry.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects on PDSS average item score after 8 weeks of double-blind treatment.;Secondary Objective: - To evaluate the effects on PDSS average item score during the 8 week double-blind treatment period and at the end of the 1 week follow-up period.<br><br>- To evaluate the proportion of patients who respond to treatment (response is defined as ≥ 50% decrease in PDSS average item score) during the 8 week double-blind treatment period and at the end of the 1 week follow-up period.<br><br>- To evaluate the effects on CGI, HAM-A, PAS-SR, PAS (Bandelow) during the 8 week double-blind treatment period and at the end of the 1 week follow-up period.<br><br>- To evaluate the safety and tolerability of ABIO 08/01 over the whole study period.<br><br>- To assess the compliance of the patient to the treatment.;Primary end point(s): Panic Disorder Severity Scale (PDSS)

Secondary Outcome Measures