Posttraumatic stress disorder
Conditions
Interventions
Doxazosin retard (extended release) 4 mg or 8 mg a day for 6 - 10 weeks.
Sponsors
Parnassia Bavo Groep (Den Haag)
Eligibility
Age
12 Years to 99 Years
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).
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 |
|---|---|
| - Items and sum of items measuring sleep quality of the Clinician Administered PTSD Scale (CAPS) as recurrent distressing dreams item and item difficulty falling or staying asleep - total sleep time (TST). - Clinical Global Impression of Change (CGIC), | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pittsburgh Sleep Quality Index (PSQI). - EEG and actimeter indices: (reduction of stage 1 sleep, increase of deep sleep stage) - Total score on CAPS - PTSD Diagnostic Scale (PDS) - Montgomery-Asberg Depression Rating Scale (MADRS) - Dissociative experiences scale (DES) and Clinician-Administered Dissociative States Scale (CADDS) - Community Assessment of Psychotic Experiences (CAPE) | — |
Countries
Netherlands
Outcome results
None listed