Dose finding study of trazodone in the treatment of patients with primary insomnia
- Conditions
- Primary Insomnia (or insomnia associated with mild non-psychotic psychiatric disorders)
- Registration Number
- EUCTR2005-002711-25-CZ
- Lead Sponsor
- ACRAF S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Patients may be enrolled under the following circumstances:
·male or female patients with no limitation of race, aged between 18 and 65 years (limits included);
·clinical diagnosis of either primary insomnia or insomnia associated with mild non-psychotic psychiatric disorders (DSM-IV code 300.9) based on subjective reporting of current history of insomnia, as defined by DSM-IV (code 307.42), presenting in the last month, at least two of the following characteristics:
·predominant complaint of difficulty of initiating or maintaining sleep, or non restorative sleep;
·sleep disturbance (or associated daytime fatigue) causing clinically significant distress or impairment in social, occupational, or other important areas of functioning;
·frequent (3 or more per night) nocturnal awakenings with difficulty returning to sleep;
·Time to Sleep Onset (TSO) > 30 min in at least three nights of the week preceding the enrolment (Visit 2);
·Total Sleep Time (TST) of 4-6 hours in at least three nights of the week preceding the enrolment (Visit 2);
·Zung Anxiety Scale score < 40
·Zung Depression Scale score < 40
·normal physical, neurological, and laboratory profile with no acute, chronic, or recurrent conditions that might affect the study;
·discontinuation of benzodiazepines or other over-the-counter sleep medication or other psychotropic drugs for 1-2 weeks, depending upon duration of action;
·consent to maintain a regular work and activity schedule, avoid naps, consume no alcohol, and have no caffeine after 15:00 hours;
·signed and dated 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
Patients cannot enter the trial under the following circumstances:
·history of occurrence of adverse reactions or known hypersensitivity to the experimental drugs and their eccipients;
·history or presence of clinically significant hepatic or renal disease or other medical disease that might compromise the study;
·serious respiratory insufficiency, myastenia gravis, narrow angle glaucoma;
·myocardial infarction within 6 months prior to start of the treatment;
·sleep disturbance occurring exclusively during the course of narcolepsy, breathing-related sleep disorders, circadian sleep disorder, or a parasomnia;
·sleep disturbance occurring exclusively during the course of another mental disorder (i.e, major depressive disorder, generalized anxiety disorder, a delirium);
·sleep disturbances due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical conditions;
·recent history of alcoholism;
·regular use of any medication that in the Investigators’ opinion would interfere with the study;
·thyroid dysfunction, even if pharmacologically corrected;
·clinically significant abnormalities on the pre-study physical examination, vital signs, ECG and laboratory tests;
·positive urine drug screen for CNS-active drugs (cocaine, amphetamines, cannabinoids, oppioids);
·concomitant diseases that might cause insomnia (i.e., pain sindromes, cardiovascular or gastrointestinal or muscle-skeletal disorders, and urological patologies characterized by nicturia);
·pregnancy, lactation, or female of childbearing age with a positive urine pregnancy test result during the screening assessment. Women of childbearing age must use a medically acceptable form of contraception during the entire study period;
·participation to another trial involving any investigational drug during the past 60 days.
The absence of any of the above mentioned inclusion criteria or presence of any of the above mentioned exclusion criteria during the course of the study will result in the withdrawal of the patient.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate in outpatients with primary insomnia the hypnotic efficacy of a two-week treatment period of trazodone 30, 60, or 90 mg once daily at bedtime;Secondary Objective: To evaluate the safety and tolerability of a two week treatment period followed by six day tapered discontinuation of trazodone 30, 60, or 90 mg once daily at bedtime. To evaluate the hang-over effects of 3 trazodone and lormetazepam dosages. ;Primary end point(s): Primary:to evaluate in outpatients with primary insomnia (or insomnia associated with mild non-psychotic psychiatric disorders) the hypnotic efficacy of a 2-week treatment period of trazodone 30, 60 or 90 mg once daily at bedtime; a control group of patients treated with lormetazepam 1 mg once daily at bedtime is also foreseen
- Secondary Outcome Measures
Name Time Method