The Effects of Quetiapine XR on Cognition, Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression

NCT00517387 | Completed Phase 3

• 1 other identifier: H07-00629
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Recently published work has examined the effects of "atypical antipsychotics" in SSRI-treatment resistant patients. In these studies, patients with unipolar depression who were treated with SSRI's, but not responsive to treatment after 4 or more weeks, were supplemented with an atypical. The atypical antipsychotics were found to diminish depression symptoms, as well as benefit sleep quality. We propose a similar study with Quetiapine XR, focusing on thinking processes, mood and anxiety. Patients with depression who are SSRI treatment resistant will be treated with Quetiapine. Cognition will be evaluated in the UBC Mood Disorders Clinic two times: first before Quetiapine addition, then after 8 weeks. Depression symptoms and other measurements will be done at the 9 time points: before Quetiapine, and each week after treatment has begun. The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to placebo as augmentation therapy in treatment of anxiety and depressive symptoms in SSRI-nonresponsive unipolar patients. Secondarily, we would like to evaluate the safety and tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients.

Conditions

Unipolar Depression

Keywords

Depression; SSRI; Atypical Antipsychotic; Cognition; Mood; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Primary outcome will be measurements of cognitive function, determined both prior to treatment and after 8 weeks of treatment.

  8 weeks

Secondary Outcomes (1)

• To evaluate Quetiapine XR compared to placebo, in SSRI-nonresponsive unipolar patients, in treatment of anxiety and depressive symptoms and biomarkers, improving patient's overall quality of life, and to evaluate its safety and tolerability.

  8 weeks

Study Arms (1)

1

ACTIVE COMPARATOR

All patients will receive Quetiapine XR at an initial dose of 50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a target dose of 300 mg/day by day 4. Tablets will be self-administered early each night.

Drug: Quetiapine XR

Interventions

Quetiapine XR DRUG

All patients will receive Quetiapine XR at an initial dose of 50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a target dose of 300 mg/day by day 4. Tablets will be self-administered early each night.

1

Eligibility Criteria

• Age: 19 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 Unipolar Depression by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV-TR)
• Females and males aged 19-65 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
• Minimum 21-item HAM-D GRID score of 15
• Prior treatment with therapeutic doses of an SSRI-type antidepressant for at least 6 weeks
• Unsatisfactory response to treatment, as determined by clinician, for at least 6 weeks.

You may not qualify if:

• Pregnancy or lactation
• English as a second language
• 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
• Previous head injury, associated with loss of consciousness.

Sponsors & Collaborators

• University of British Columbia: lead
• AstraZeneca: collaborator

Study Sites (1)

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2A1, Canada

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Allan Young, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 16, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

CA (1)