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Doxazosine voor PTSS, met name voor de slaapstoornissen.


- candidate number14354
- NTR NumberNTR3848
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2013
- Secondary IDsNL41043.058.12 METC LUMC
- Public TitleDoxazosine voor PTSS, met name voor de slaapstoornissen.
- Scientific TitleAn open label study with objective sleepregistration on the effects of Doxazosin as treatment for PTSD, especially for sleep disturbance.
- ACRONYMDoPS
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD), Sleep disorders
- Inclusion criteria1. Good speaking and writing in Dutch;
2. PDS above 18;
3. CAPS recurrent distressing dreams item score above 5 - CAPS difficulty falling or staying asleep item above 5;
4. No medication that affects sleep (e.g. contraceptives or analgetics like paracetamol are allowed);
5. No alcohol more than two consumptions a day;
6. Medication use of psychotropics has stopped at least one month before entrance of the study;
7. 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 criteriaPsychiatric:
1. Lifetime schizophrenia;
2. Schizoaffective disorder;
3. Bipolar disorder;
4. Severe depressive disorder;
5. Cognitive disorder;
6. Current delirium;
7. Substance use within 2 months of the study; alcohol is allowed if not more than 2 consumptions a day;
8. Severe psychiatric instability (including evidence of being actively suicidal or homicidal);
9. Any behavior which poses an immediate danger to patient or others.

Somatic:
1. Preexisting hypotension or (anamnestic) orthostatic hypotension;
2. Hypertension unless stable with help of anti-hypertensive medication;
3. Known for severe ischaemic heart disease;
4. Disease with strong reduced functioning of the liver;
5. Women of childbearing potential with either positive pregnancy test or refusal to use effective birth control method;
6. Allergy or previous adverse reaction to doxazosin or other alpha-1 antagonist;
7. Hypersensitivity to quinazolinderivates;
8. Known for hypertrophy of the prostate without treatment;
9. Gastro-intestinal obstruction;
10. Oesophageal obstruction;
11. Overflow bladder or anuria with or without progressive renal insufficiency.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-feb-2013
- planned closingdate
- Target number of participants20
- InterventionsAfter three weeks of placebo-use and baseline measurements including one week sleepregistration participants use for 2 weeks 4mg doxazosine with extended release then go to 8mg if possible. After two more weeks use of doxazosin extended release measurements are repeated. During the trial several times some measurements will be taken and pulse and bloodpressure measured.
- Primary outcome1. 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;
2. Total sleep time (TST);
3. The MIRECC version of the Global Assessment of Functioning scale.
- Secondary outcome1. Pittsburgh Sleep Quality Index (PSQI);
2. Ambulatory sleepregistration (Neuroporti) and actimeter indices;
3. Total score on CAPS;
4. PTSD Diagnostic Scale (PDS);
5. Montgomery-Asberg Depression Rating Scale (MADRS);
6. Dissociative experiences scale (DES) and Clinician-Administered Dissociative States Scale (CADDS);
7. Prodromal Questionnaire (PQ-16).
- Timepoints1. Start: All baseline measurements (CAPS, PDS, CADDS, MADRS, PQ-16, MIREC-GAF, DES, PSQI, Possible side-effects, pulse-bloodpressure) except sleepregistration and actimeter;
2. After two weeks: Sleepitems of CAPS, PDS, CADDS, MIREC GAF, pulse-bloodpressure, side-effects;
3. After two weeks start of one week sleepregistration and actimeter, and after three weeks also: CAPS, PDS, CADDS, MADRS, PQ-16, MIREC-GAF, DES, PSQI, Possible side-effects, pulse-bloodpressure;
4. Five weeks: Sleepitems of CAPS, PDS, CADDS, MIREC GAF, pulse-bloodpressure, side-effects;
5. Seven weeks: Sleepitems of CAPS, PDS, CADDS, MIREC GAF, pulse-bloodpressure, side-effects;
6. Nine weeks: Sleepitems of CAPS, PDS, CADDS, MIREC GAF, pulse-bloodpressure, side-effects;
7. After nine weeks: One week of ambulatory sleepregistration and actimeter and CAPS, PDS, CADDS, MADRS, PQ-16, MIREC-GAF, DES, PSQI, Possible side-effects, pulse-bloodpressure.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J.P. Jong, de
- CONTACT for SCIENTIFIC QUERIES J.P. Jong, de
- Sponsor/Initiator Parnassia, psycho-medische zorg, PsyQ/Mondriaan
- Funding
(Source(s) of Monetary or Material Support)
ParnassiaGroep, PsyQ
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-feb-2013 - 19-feb-2013


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