Somatization disorder (ICD 10, F45.0)
Conditions
Interventions
The patients take two tablets (daily dose: placebo or Dalumin 600 mg or Dalumin 1200 mg) in the morning orally for 70 days. Randomization is carried out by a member of the sponsor who is not directly
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of somatisation disorder 2. Undifferentiated somatoform disorder or pain disorder 3. Aged over 18 years 4. Severity of disorder: HAMAsom score = 12, SSIsp 3 of 5 items = moderate 5. BMI between 18 and 29.9 kg/m2 6. Written informed consent 7. Use of two different forms of highly effective contraception by females with childbearing potential
Exclusion criteria
Exclusion criteria: 1. Any axis I disorder other than study indication within 6 months before the study 2. Risk of suicide or previous suicide attempt or clear display of autoaggressive behavior 3. History or evidence of alcohol and/or substance abuse or dependence 4. Current use of other psychotropic drugs within fivefold half-life of the drug before the baseline visit 5. History of hypersensitivity to Filipendula ulmaria or salicylates 6. Any unstable acute medical disorder 7. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment 8. Non-medical psychiatric treatment during the course of the study 9. Clinical significant abnormality of ECG and/or laboratory value(s) 10. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The individual difference of the total score of the Hamilton Rating Scale for Anxiety, somatic subscore (HAMAsom) between baseline and end of treatment (Week 10 or end of treatment in case of premature study termination) 2. Individual difference of the total score of the Somatic Symptom Inventory subset pain (SSIsp) between baseline and end of treatment (Week 10 or end of treatment in case of premature study termination) comparing Dalumin and placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response criteria based on the HAMAsom total and on the SSIsp total score 2. Difference of the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) between baseline and end of treatment. Response criteria based on the MADRS total score 3. Individual difference of single items of the HAMAsom, single items of the MADRS, total score and single items of the SSIsp; total score and subscales of the Sheehan Disability 4. Clinical Global Impressions of severity of disorder (CGI - item 1): Clinical Global Impressions of change from baseline (CGI - item 2) 5. Visual Analogue Scale overall pain (VASop) 6. Symptom Checklist 90 (SCL 90) 7. Frequency of patients who discontinue the study prematurely due to inefficacy 8. Adverse events, Laboratory data, ECG, vital signs | — |
Countries
Germany
Outcome results
None listed