Posttraumatic stress disorder
Conditions
Interventions
Product Name: Doxazosin
Pharmaceutical Form: Capsule
Sponsors
ParnassiaBavoGroup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Good speaking and writing in Dutch - PDS above 18 - CAPS recurrent distressing dreams item score above 5 - CAPS difficulty falling or staying asleep item above 5 - No medication except contraceptives or analgetics like paracetamol - No alcohol more than two consumptions a day - Medication use of psychotropics has stopped at least one month before entrance of the study - If psychotherapy has not been started yet it will not be initiated during the trial; If started it will be paused for the period of the study. Medication with influence on sleep-EEG will not be started during the study period (paracetamol and contraceptives are allowed). 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Psychiatric: - Lifetime schizophrenia, - schizoaffective disorder, - bipolar disorder, - severe depressive disorder (MADRS > 34) (for screening: QIDS > 15) - cognitive disorder, - current delirium, - substance use within 2 months of the study; alcohol is allowed if not more than 2 consumptions a day. - severe psychiatric instability (including evidence of being actively suicidal or homicidal). - any behavior which poses an immediate danger to patient or others. Somatic: - preexisting hypotension or (anamnestic) orthostatic hypotension - hypertension unless stable with help of anti-hypertensive medication. - Known for severe ischaemic heart disease - disease with strong reduced functioning of the liver. - Women of childbearing potential with either positive pregnancy test or refusal to use effective birth control method. - Allergy or previous adverse reaction to doxazosin or other alpha-1 antagonist. - Hypersensitivity to quinazolinderivates - Known for hypertrophy of the prostate without treatment. - Gastro-intestinal obstruction - oesophageal obstruction - overflow bladder or anuria with or without progressive renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective: The purpose of this study is to evaluate the effect on sleep and ptsd of the drug doxazosin in patients with PTSD who also have sleep problems. ;Secondary Objective: Not applicable;Primary end point(s): Main study parameters/endpoints: Primary outcome: ;Timepoint(s) of evaluation of this end point: at baseline measurements will be done; as well as during placebo-run-in period, during use of 4 mg doxazosin a day and using "best dosage" (4 or 8 mig a day). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome: total score on CAPS and CAPS subscale score (Reexperiencing/ Intrusions, Avoidance/Numbing and Hyperarousal), score on PTSD Diagnostic Scale (PDS), on.Montgomery-Asberg Depression Scale (MADRS), Clinical Global Impression of Change (CGIC), dissociative experiences scale (DES) and Clinician-Administered Dissociative States Scale (CADDS), psychotic symptoms with help of The Community Assessment of Psychic Experiences (CAPE), Sleep 50 and pulse / Blood- pressure.;Timepoint(s) of evaluation of this end point: at baseline measurements will be done; as well as during placebo-run-in period, during use of 4 mg doxazosin a day and using "best dosage" (4 or 8 mig a day). | — |
Countries
Netherlands
Contacts
Public ContactJoop de Jong
ParnassiaBavoGroup
Outcome results
None listed