Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
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|ClinicalTrials.gov Identifier: NCT01971203|
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Generalized Anxiety Disorder||Drug: seroquel xr Behavioral: CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Randomized, Active Controlled Study of the Efficacy and Safety of Extended-release Quetiapine Fumarate (Seroquel XR) as Adjunctive Medication Therapy to Cognitive Behavioral Therapy in the Treat,Ent of Patients With Comorbid Major Depression and Generalized Anxiety Disorder|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: seroquel xr
quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day 16 weeks of treatment including CBT
Drug: seroquel xr
Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day
Other Name: quetiapine XR
Placebo Comparator: placebo plus CBT
treatment group receiving placebo pill plus CBT
16 weeks of treatment
Other Name: cognitive behavioral therapy
- MADRS [ Time Frame: baseline and 16 weeks ]Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.
- HAM-A [ Time Frame: baseline and 16 weeks ]Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.
- Clinical Global Impression Scales for Severity and Improvement [ Time Frame: up to 16 weeks ]The Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).
- Changes in Sexual Functioning Questionnaire (CSFQ) [ Time Frame: baseline and week 16 ]Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971203
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Jack Hirschowitz, MD||Icahn School of Medicine at Mount Sinai|