Bipolar Type II DisorderPhase 4NCT00641927
Antidepressant Therapy for Bipolar II Major Depression
A Phase 4 study testing Venlafaxine and Lithium Carbonate in people with Bipolar Type II Disorder, run by Stanley Medical Research Institute at 1 site in United States.
Trial summary
This study examines the relative safety and benefit of antidepressant therapy (versus recommended mood stabilizer therapy)of bipolar type II major depressive episode. We hypothesize that antidepressant therapy will be superior to mood stabilizer therapy with little or no difference in treatment emergent manic symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Type II Disorder
- What is being tested?
- Venlafaxine and Lithium Carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women (all races and ethnicity) greater than or equal to18 years of age,
- DSM IV diagnosis of BP II disorder,
- Current DSM IV MDE,
- HAM-D17 score greater than or equal to 16,
- Drug free from prior psychotropic medication greater than or equal to 7 days (2 weeks for MAOIs)
Who cannot join
- History of mania,
- Other primary DSM IV Axis I diagnosis,
- Alcohol or drug dependence within 3 months,
- History of nonresponse to Effexor-XR or lithium in the present MDE,
- History of allergic reaction to Effexor-XR or lithium,
- Medical contraindications to treatment with Effexor-XR or lithium,
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- Unstable medical condition,
- Pregnant or breast-feeding women,
- Women of child-bearing potential not using a medically approved form of contraception,
- Actively suicidal or requiring hospitalization,
- Requiring concurrent antidepressant, neuroleptic or mood stabilizer therapy,
- Prior investigational study within 4 weeks of starting active therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Research Unit, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309
About this study
Official title: Acute Antidepressant Therapy in Bipolar II Major Depression
This study examines the relative safety and benefit of antidepressant therapy (versus recommended mood stabilizer therapy)of bipolar type II major depressive episode. We hypothesize that antidepressant therapy will be superior to mood stabilizer therapy with little or no difference in treatment emergent manic symptoms.
Read the detailed description
Bipolar type II (BP II) major depressive episode (MDE), affects 2.5% of the US adult population and results in an estimated healthcare cost of $40 billion annually. BP II disorder is a distinct clinical entity that differs from BP I disorder, and is characterized by a preponderance of MDEs that result in particularly high morbidity and mortality rates. The treatment of BP II MDE remains a challenge for clinicians. Concerns over antidepressant drug (AD) induced manic switch episodes have led current practice guidelines to recommend treating BP II MDE with mood stabilizer (MS) monotherapy and to avoid AD monotherapy. To date, there are no controlled clinical trials to test the validity of these empirical guidelines. Results from our preliminary BP II MDE studies have shown that fluoxetine monotherapy may be safe and effective initial treatment of BP II MDE with a low manic switch rate. Based upon these observations, we now ask (Specific aim #1): "What is the relative safety and efficacy of initial AD monotherapy vs. MS monotherapy of BP II MDE?" and "What is the relative manic switch rate of initial AD vs. MS monotherapy of BP II MDE?" To answer these questions, patients with BP II MDE will be treated in a 12-week, randomized, parallel group comparison of venlafaxine monotherapy vs. lithium monotherapy. We hypothesize that AD monotherapy will have superior efficacy vs. MS monotherapy, and that there will be a similar manic switch rate among both treatment conditions. If our hypotheses are correct, we believe that these results may have an important public health impact on the current practice guidelines for treating BP II MDE.
- Conditions
- Bipolar Type II Disorder
- Being tested
- Venlafaxine, Lithium Carbonate
- Keywords
- bipolar disorder, bipolar type II disorder, antidepressant, mood stabilizer, venlafaxine, lithium carbonate
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Effexor-XR
37.5 mg - 375 mg daily, 12 Weeks
Lithium CarbonateDrug
Also called Lithium
300 mg - 2100 mg daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antidepressant Receives: Drug: Venlafaxine |
| 2 | Active comparator | Drug Receives: Drug: Lithium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hamilton Depression Rating Scale score.
Measured: 12 Weeks
Secondary outcomes (1)
Change in Young Mania Rating Scale score.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startApr 2002
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar Type II DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanley Medical Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Jay D Amsterdam, MD, Principal investigator, Depression Research Unit, School of Psychiatry, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641927
- Sponsor's protocol ID
- 01-005
- Status last verified
- Mar 2008
- First submitted
- 18 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shults J, Sun W, Tu X, Kim H, Amsterdam J, Hilbe JM, Ten-Have T. A comparison of several approaches for choosing between working correlation structures in generalized estimating equation analysis of longitudinal binary data. Stat Med. 2009 Aug 15;28(18):2338-55. doi: 10.1002/sim.3622.
PubMed 19472307
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Antidepressant Therapy in Bipolar II Major Depression
- ClinicalTrials.gov ID
- NCT00641927
- Acronym / sponsor ID
- 01-005
- Conditions
- Bipolar Type II Disorder
- Keywords
- bipolar disorder, bipolar type II disorder, antidepressant, mood stabilizer, venlafaxine, lithium carbonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanley Medical Research InstituteUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the relative safety and benefit of antidepressant therapy (versus recommended mood stabilizer therapy)of bipolar type II major depressive episode. We hypothesize that antidepressant therapy will be superior to mood stabilizer therapy with little or no difference in treatment emergent manic symptoms.
Detailed description
Bipolar type II (BP II) major depressive episode (MDE), affects 2.5% of the US adult population and results in an estimated healthcare cost of $40 billion annually. BP II disorder is a distinct clinical entity that differs from BP I disorder, and is characterized by a preponderance of MDEs that result in particularly high morbidity and mortality rates. The treatment of BP II MDE remains a challenge for clinicians. Concerns over antidepressant drug (AD) induced manic switch episodes have led current practice guidelines to recommend treating BP II MDE with mood stabilizer (MS) monotherapy and to avoid AD monotherapy. To date, there are no controlled clinical trials to test the validity of these empirical guidelines. Results from our preliminary BP II MDE studies have shown that fluoxetine monotherapy may be safe and effective initial treatment of BP II MDE with a low manic switch rate. Based upon these observations, we now ask (Specific aim #1): "What is the relative safety and efficacy of initial AD monotherapy vs. MS monotherapy of BP II MDE?" and "What is the relative manic switch rate of initial AD vs. MS monotherapy of BP II MDE?" To answer these questions, patients with BP II MDE will be treated in a 12-week, randomized, parallel group comparison of venlafaxine monotherapy vs. lithium monotherapy. We hypothesize that AD monotherapy will have superior efficacy vs. MS monotherapy, and that there will be a similar manic switch rate among both treatment conditions. If our hypotheses are correct, we believe that these results may have an important public health impact on the current practice guidelines for treating BP II MDE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VenlafaxineAntidepressant |
| 2 | Active comparator | Drug: Lithium CarbonateDrug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- men and women (all races and ethnicity) greater than or equal to18 years of age,
- DSM IV diagnosis of BP II disorder,
- Current DSM IV MDE,
- HAM-D17 score greater than or equal to 16,
- Drug free from prior psychotropic medication greater than or equal to 7 days (2 weeks for MAOIs)
Key exclusion criteria (12 listed)
- History of mania,
- Other primary DSM IV Axis I diagnosis,
- Alcohol or drug dependence within 3 months,
- History of nonresponse to Effexor-XR or lithium in the present MDE,
- History of allergic reaction to Effexor-XR or lithium,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenlafaxineAlso: Effexor-XR37.5 mg - 375 mg daily, 12 Weeks | Drug | 1 |
| Lithium CarbonateAlso: Lithium300 mg - 2100 mg daily, 12 weeks | Drug | 2 |
Primary outcome
Reduction in Hamilton Depression Rating Scale score.
Time frame: 12 Weeks
1 secondary outcome
Change in Young Mania Rating Scale score.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
- Derived from this study: PubMed 19472307Shults J, Sun W, Tu X, Kim H, Amsterdam J, Hilbe JM, Ten-Have T. A comparison of several approaches for choosing between working correlation structures in generalized estimating equation analysis of longitudinal binary data. Stat Med. 2009 Aug 15;28(18):2338-55. doi: 10.1002/sim.3622.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay D Amsterdam, MD principal investigator
Depression Research Unit, School of Psychiatry, University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venlafaxine and Lithium Carbonate in people with Bipolar Type II Disorder, run by Stanley Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hamilton Depression Rating Scale score. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2008.