Bystritsky 1995.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III panic disorder with or without agoraphobia Method of diagnosis: Not stated Age: average age of 37 years, no between‐group differences Sex: 12 males and 9 females, no between‐group differences Location: USA; setting unclear Co‐morbidities: lack of significant drug or alcohol history or significant medical illness; patients that had an additional diagnosis of major depression (MD) or generalised anxiety disorder (GAD) were allowed to participate only if they presented a predominant picture of panic disorder and if panic symptoms preceded the onset of the current episode of MD or GAD Rescue medication: Not stated. |
|
Interventions | Participants were randomly assigned to either: (1) desipramine arm (n = 11) Duration: 10 weeks Treatment Protocol: flexible dosage; range = 10 ‐ 300 mg, M = 110, SD = 49 (2) fluoxetine arm (n = 11) Duration: 10 weeks Treatment Protocol: flexible dosage; range = 2.5 ‐ 60 mg, M = 19, SD = 10 |
|
Outcomes |
Time points for assessment: weekly Outcomes: 1. Hamilton Rating Scale for Anxiety (HAMA) 2. Hamilton Rating Scales for Depression (HAM‐D) 3. Four Dimensional Anxiety Scale 4. Clinical Global Impression‐Severity of Illness (CGI‐S) 5. Clinical Global Impression‐Improvement (CGI‐I) |
|
Notes |
Date of study: Not stated Funding source: this research has been supported in part by NIMH grant MH 45342‐02 and by an NPI Opportunity Grant Declarations of interest among the primary researchers: None. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "they were assigned randomly". No further details. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "both patients and investigators were blind to the assignment"; "patients were administered identical capsules labeled A, B or C: Capsules A, containing 2,5 mg of fluoxetine or 10 mg of desipramine were administered for one week [...], capsules B (containing) 25 mg of desipramine or 5 mg of fluoxetine, (capsules) C (containing) 50 mg of desipramine or 10 mg of fluoxetine". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "both patients and investigators were blind to the assignment" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No clear information on incomplete outcome data management. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Unclear risk | Quote: "this research has been supported in part by NIMH grant MH 45342‐02 and by an NPI Opportunity Grant". |