Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression

NCT ID: NCT00188643

Last Updated: 2011-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2007-01-31

Brief Summary

The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and lamotrigine.

Detailed Description

The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and lamotrigine.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Venlafaxine and Lamotrigine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Meets DSM-IV criteria for a diagnosis of Bipolar I disorder, most recent episode depression, or bipolar II disorder, most recent episode depression using the structured clinical interview for DSM-IV Axis 1 disorders 2. Subjects must have a Hamilton depression rating scale score of >16. 3. Patients at visit 1 must have documented trials (levels must be obtained) of their mood stabilizer for at least 2 weeks 4. Subjects must be between the ages of 18-70, male or female 5. Treatment with oral antipsychotics, anticonvulsants or benzodiazepines prior to enrolment or during the study will be permitted, but not other antidepressants.

6. Female patients of childbearing potential must be using a medically accepted means of contraception.

7. Patient is judged by the investigator to be in generally good health 8. Education level and a degree of understanding is such that the patient can communicate effectively with the investigator.

9. Patient must be capable of providing informed consent.

Exclusion Criteria

• 1. Treatment with antidepressant medication within one day prior to visit 1 or during the protocol.

2. Patients previously showing poor therapeutic response to venlafaxine XR or lamotrigine 3. Judged clinically to be at serious suicidal risk. 4. DSM-IV criteria for substance dependence (except nicotine or caffeine) within the past 30 days 5. Course of ECT (electroconvulsive therapy) in the preceding 4 weeks prior to visit 1 or during the protocol.

6. Patients who suffer from a major neurological or medical illness. 7. Current diagnosis of schizophrenia or other psychotic disorders as defined in the DSM-IV 8. Uncorrected hypothyroidism or hyperthyroidism 9. Female patients who are either pregnant or nursing 10. Elevated thyroid stimulating hormone (TSH).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Roger McIntyre, MD,FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id