Den Boer 1988.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III panic disorder without phobic avoidance or panic disorder with severe phobic avoidance behaviour Method of diagnosis: Not stated Age: for maprotiline, M = 35.0 (SD = 7.4); for fluvoxamine, M = 37.3 (SD = 10.6) Sex: for maprotiline, 4 males and 20 females; for fluvoxamine 5 males and 15 females Location: the Netherlands; setting: outpatients Co‐morbidities: patients with major affective disorders, schizophrenia, other psychotic disorder or significant medical problems were excluded Rescue medication: Not stated |
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Interventions |
Participants were randomly assigned to either: (1) maprotiline arm ("24 patients were included in the maprotiline group") Duration: 6 weeks Treatment Protocol: flexible dosage; range = 50 ‐ 150 mg, M and SD not provided (2) fluvoxamine arm ("20 patients were included in the fluvoxamine group") Duration: 6 weeks Treatment Protocol: flexible dosage; range = 50 ‐ 150 mg, M and SD not provided |
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Outcomes |
Time points for assessment: baseline and weekly Outcomes: 1. SCL‐90 2. State Anxiety Inventory (A‐STATE) 3. Self Rating Depression Scale (SDS) 4. Hamilton Anxiety Scale (HAS) 5. Hamilton Depression Scale (HDS) 6. panic attack inventory 7. side‐effects scale |
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Notes |
Date of study: Not stated Funding source: Not stated Declarations of interest among the primary researchers: Not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "they were randomly allocated". No further details. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote "double‐blind treatment". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote "double‐blind treatment". No further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Number of patients randomised per group not reported (number of total randomised patients = 47); only number of patients evaluated per group was available, respectively 24 in maprotiline group and 20 in fluvoxamine. |
Selective reporting (reporting bias) | High risk | Continuous outcome data are reported only in graphs. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |