[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Comparison
Included criteria: Male and femalepatients were allowed in the study if they were8–17 years of age, met Diagnostic and StatisticalManual of Mental Disorders, fourth edition(DSM-IV; American Psychiatric Association1994) criteria for OCD (300.30) as their predominantpsychiatric diagnosis, and had a Children’sYale-Brown Obsessive Compulsive Scale(CY-BOCS; Scahill et al. 1997) score 16 or moreat entry
Excluded criteria: Any axis I disorderother than OCD as the predominant diagnosis(defined as that disorder that is the primaryfocus of treatment, including mood disorder, psychosis, disruptive behavior disorders, eatingdisorder, Tourette syndrome, pervasive developmentaldisorders, and non-OCD anxietydisorder); history of seizure disorder, mentalretardation, or recent substance abuse; serioussuicidal or homicidal risk; patients requiringconcomitant behavioral therapy, psychotherapy, or concomitant therapy with other psychotropicdrugs; and pregnancy were all reasons forstudy exclusion.
Pretreatment:
Intervention Characteristics
Intervention
Comparison
Antal genhenvisninger: Efter udtrapning (indenfor 6 mdr.)
Angst: End of treatment
Social funktionsevne: Efter udtrapning (indenfor 6 mdr.)
Livskvalitet: Efter udtrapning (indenfor 6 mdr.)
Drop-out: End of Treatment
Symptomscore (CY-BOCS/Y-BOCS: ≤ 9) : Efter udtrapning (indenfor 6 mdr.)
Symptomscore (CGI-I: >4/ CGI-S: ≤ 2): Efter udtrapning (indenfor 6 mdr.)
Frafald på grund af bivirkninger (AE): End of treatment
Alvorlige bivirkninger (SAE): End of treatment
relapse Efter udtrapningen (indenfor 6 mdr)
Sponsorship source: Supported by an unrestricted grant from GlaxoSmithKline Pharmaceuticals.
Country: US
Setting:
Comments:
Authors name: Daniel A. Geller, Joseph Biederman, S. Evelyn Stewart, Benjamin Mullin, Colleen Farrell, Karen Dineen Wagner, Graham Emslie, David Carpenter
Institution: Obsessive Compulsive Disorder Program and Pediatric Psychopharmacology Research Program
Email:
Address: MassachusettsGeneral Hospital, Boston, Massachusetts
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Comparison
Included criteria:
Excluded criteria:
Pretreatment:
Intervention Characteristics
Intervention
Comparison
Antal genhenvisninger: Efter udtrapning (indenfor 6 mdr.)
Angst: End of treatment
Social funktionsevne: Efter udtrapning (indenfor 6 mdr.)
Livskvalitet: Efter udtrapning (indenfor 6 mdr.)
Drop-out: End of Treatment
Symptomscore (CY-BOCS/Y-BOCS: ≤ 9) : Efter udtrapning (indenfor 6 mdr.)
Symptomscore (CGI-I: >4/ CGI-S: ≤ 2): Efter udtrapning (indenfor 6 mdr.)
Frafald på grund af bivirkninger (AE): End of treatment
Alvorlige bivirkninger (SAE): End of treatment
relapse Efter udtrapningen (indenfor 6 mdr)
Sponsorship source: Dr. Hollander has been a consultant for, has received grant/research support from, and has served on the spreakers/advisory board for GlaxoSmithKline; Dr.Steiner is an employee of GlazoSmithKline; Dr. Wheadon is an employee of and a major stockholder in GlaxoSmithKline; and Dr. Burnham is an emplyww of SmithKline Beecham Pharmaceuticals.
Country: US
Setting:
Comments:
Authors name: Eric Hollander for the Paroxetine OCD Study Group
Institution: Department of Psychiatry, Mount Sinai School of Medicince. NY
Email: eric.hollander@mssm.edu
Address: One Gustave L. Levy Place. NY
Birgitte Holm Petersen on 30/09/2015 19:04
Dichotomous Outcomes
relapse : CGI-S 1 point drop from baseline
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Comparison
Included criteria: male and female outpatients 18 years of ageand older who met DSM-III-R criteria for obsessive-compulsivedisorder as determined by the Structured Clinical Interview forDSM-III-R (SCID-P) (18). At baseline, the patients had to have aminimum total score of 20 on the Yale-Brown Obsessive CompulsiveScale (19, 20) and a score of at least 7 on the NIMH Global ObsessiveCompulsive Scale (21)
Excluded criteria: 1. Having a total score on the 24-item Hamilton DepressionRating Scale (22) of 17 or higher.2. Being a woman who was currently pregnant or lactating or ofchildbearing potential and not using a medically accepted formof contraception.3. Having a current diagnosis of organic mental disorder, majordepression, bipolar disorder, Tourette’s syndrome, or a severe axisII personality disorder or a principle diagnosis of trichotillomania,somatoform disorder, panic disorder, social phobia, or generalizedanxiety disorder.4. Having a current or verified past diagnosis of schizophrenia,delusional disorder, or other psychosis.5. Having a DSM-III-R-defined diagnosis of alcohol or substanceabuse and/or dependence in the past 6 months6. Having a positive urine drug screening test.7. Having any medical contraindications to treatment with sertraline.8. Having a history or evidence of malignancy other than excisedbasal cell carcinoma.9. Having an acute or unstable medical illness.10. Participating in an investigational drug study within 28 daysbefore entering the study.11. Taking sertraline within 2 months of study entry, not respondingto an adequate trial of sertraline in the past, or participatingin an investigational study of sertraline.12. Concomitantly using any psychotropic medication (otherthan chloral hydrate for sleep).13. Receiving concurrent behavior therapy for OCD.14. Receiving treatment with an monoamine oxidase inhibitorwithin 2 weeks, a depot neuroleptic within 6 months, fluoxetinewithin 5 weeks, or a neuroleptic, anxiolytic, or antidepressant ona daily basis in the 2 weeks before the first administration of sertraline.15. Having a test of liver function showing a level at more thantwice the upper limit of normal on the first day of the washoutperiod.16. Being illiterate, or, in the investigator’s judgment, unable orunlikely to follow the study protocol for the full 80 weeks.
Pretreatment:
Intervention Characteristics
Intervention
Comparison
Antal genhenvisninger: Efter udtrapning (indenfor 6 mdr.)
Angst: End of treatment
Social funktionsevne: Efter udtrapning (indenfor 6 mdr.)
Livskvalitet: Efter udtrapning (indenfor 6 mdr.)
Drop-out: End of Treatment
Symptomscore (CY-BOCS/Y-BOCS: ≤ 9) : Efter udtrapning (indenfor 6 mdr.)
Symptomscore (CGI-I: >4/ CGI-S: ≤ 2): Efter udtrapning (indenfor 6 mdr.)
Frafald på grund af bivirkninger (AE): End of treatment
Alvorlige bivirkninger (SAE): End of treatment
relapse Efter udtrapningen (indenfor 6 mdr)
Sponsorship source: Supported by a grant from Pfizer.Inc.
Country: US
Setting:
Comments:
Authors name: Lorrin M. Koran, Elizabeth Hackett, Arkady Rubin, Robert Wolkow, Delbert Robinson
Institution: From the Department of Psychiatry, Stanford University; the Research Department
Email: lkoran@stanford.edu
Address: OCD Clinic, Rm. 2363, Department of Psychiatry, 401Quarry Rd., Stanford,
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Comparison
Included criteria: Obsessive-compulsivesymptoms were of at least moderate severity, asdefined by a score of 19 or greater on the Yale-Brown ObsessiveCompulsive Scale (Y-BOCS)25, 26 and by a ratingof moderate or worse on the Clinical Global Impressions(CGI) Severity scale.27 Patients had no serious medicalconditions and normal clinical laboratory findings.
Excluded criteria: Patients with comorbid schizophrenia, bipolar disorder,Tourette syndrome (or other tic disorder), borderlinepersonality disorder, or psychotic features were excluded.If present, comorbid depression was considereda result of OCD. Patients were excluded if they werepreviously nonresponsive to adequate fluoxetine treatmentor were exposed to fluoxetine within the preceding8 weeks. Patients were not receiving or planning tobegin any concomitant treatment for OCD or depressionother than supportive psychotherapy at any timeduring the study. Pregnant or lactating patients werealso excluded from the protocol
Pretreatment:
Intervention Characteristics
Intervention
Comparison
Antal genhenvisninger: Efter udtrapning (indenfor 6 mdr.)
Angst: End of treatment
Social funktionsevne: Efter udtrapning (indenfor 6 mdr.)
Livskvalitet: Efter udtrapning (indenfor 6 mdr.)
Drop-out: End of Treatment
Symptomscore (CY-BOCS/Y-BOCS: ≤ 9) : Efter udtrapning (indenfor 6 mdr.)
Symptomscore (CGI-I: >4/ CGI-S: ≤ 2): Efter udtrapning (indenfor 6 mdr.)
Frafald på grund af bivirkninger (AE): End of treatment
Alvorlige bivirkninger (SAE): End of treatment
relapse Efter udtrapningen (indenfor 6 mdr)
Sponsorship source: Supported by a clinical research grant from Eli Lilly and Company.
Country: US
Setting:
Comments:
Authors name: STEVEN ROMANO, WAYNE GOODMAN, ROY TAMURA, JILL GONZALES AND THE COLLABORATIVE RESEARCH GROUP
Institution: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana;
Email:
Address: Lilly Corporate Center 2423, Indianapolis, IN46285.
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
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Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
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Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Double blinded
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
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Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
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State how the possibility of selective outcome reporting was examined by the review authors and what was found.
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Judgement Comment: described the presence of a protocol but no link to protocol
Judgement Comment: no protocol or ethical approval described
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Unpublished
Judgement Comment: Funded by GlaxoSmithKline
Judgement Comment: Dr. Hollander has been a consultant for, has received grant/research support from, and has served on the spreakers/advisory board for GlaxoSmithKline; Dr.Steiner is an employee of GlazoSmithKline; Dr. Wheadon is an employee of and a major stockholder in GlaxoSmithKline; and Dr. Burnham is an emplyww of SmithKline Beecham Pharmaceuticals.
Judgement Comment: Supported by Pfizer.
Judgement Comment: clinical research grant from Eli Lilly and Company