Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines

NCT01244711 | Terminated Phase 4 Results

• 1 other identifier: IRUSQUET0483
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and indices of psychosocial function will all improve, while BZ use will decrease significantly during a twelve-week trial period of substituting quetiapine for benzodiazepines.

Conditions

Major Depression; Generalized Anxiety Disorder

Keywords

Major Depression; Generalized Anxiety Disorder; Benzodiazepine; Quetiapine

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)

  For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).

  12 weeks

Study Arms (1)

Quetiapine

EXPERIMENTAL

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

Drug: quetiapine

Interventions

quetiapine DRUG

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

Also known as: Seroquel-XR

Quetiapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• A diagnosis of a current major depressive episode (n =20) or generalized anxiety disorder (n = 20) of at least 4 weeks duration, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) and assessed on the SCID. Subjects may be included if they meet criteria for double depression, i.e., current major depression with antecedent dysthymic disorder, major depression in partial remission or bipolar depression. MDD subjects must have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake \>/= 20. GAD subjects must have a Hamilton Anxiety Rating Scale Score (HAM-A) at intake \>/= 20. Patients who meet criteria for current GAD only during a current episode of MDD will be considered to have MDD, according to DSM-IV convention.
• Females and/or males aged 18-65 years
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
• Able to understand and comply with the requirements of the study
• All subjects must report BZ use more days than not persistent for more than 6 months and a stable regimen of mood stabilizers and/or antidepressant medication for at least 8 weeks.

You may not qualify if:

• Pregnancy or lactation
• Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning and conduct of the study
• Previous enrolment or randomisation of treatment in the present study.
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• AstraZeneca: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: james kocsis
• Organization: Weill Cornell Medical College

jhk2002@med.cornell.edu

212-746-5913

Study Officials

• james h kocsis, md

  weill cornell mc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 3, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-03

Locations

US (1)