AzTrials
AzTrials

Bipolar DisorderPhase 4NCT00602537

Antidepressant Therapy in Treating Bipolar Type II Major Depression

A Phase 4 study testing Venlafaxine and Lithium Carbonate in people with Bipolar Disorder and Depression, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder, Depression
What is being tested?
Venlafaxine and Lithium Carbonate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
Dec 2007to Jun 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Meets DSM-IV criteria for Axis I bipolar II disorder
  • Meets DSM-IV criteria for Axis I major depressive episode
  • Score of 16 on 17-item HAM-D rating scale
  • Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry
  • Willing to use an effective form of birth control throughout the study

Who cannot join

  • History of mania
  • Current primary Axis I diagnosis other than bipolar II disorder
  • Alcohol or drug dependence within 3 months prior to study entry
  • Contraindication to treatment with venlafaxine or lithium
  • Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)
  • Pregnant or breastfeeding
Show all 15Show fewer
  • Experiencing suicidal thoughts
  • Requires hospitalization
  • Requires concurrent neuroleptic or MS therapy
  • Requires concurrent AD therapy
  • Current psychotic features
  • Inadequate trial of therapy at the time of initial screening visit
  • History of intolerance to either venlafaxine or lithium
  • Unlikely to participate in a 36-week trial
  • Presence of apparent secondary gain

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Depression Research Unit - University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-3309

Other trials in United States

About this study

Official title: Treatment of Bipolar Type II Major Depression

This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.

Read the detailed description

Bipolar type II (BP II) depression affects 2.5% of the U.S. adult population. People with BP II disorder do not experience the manic episodes that are characteristic of BP I disorder, but rather they experience more modest mood swings with a greater number of major depressive episodes (MDEs). These MDEs are associated with high rates of disease and death. The treatment of BP II depression remains a challenge for clinicians. Mood stabilizer (MS) monotherapy is the current recommended treatment for BD II MDE, but there is reason to believe that antidepressant drug (AD) monotherapy could also be an effective treatment. However, concerns over AD-induced manic switch episodes have limited the use of this treatment option. Preliminary studies using the ADs fluoxetine or venlafaxine have shown success in treating and lowering the manic switch rate of those with BP II MDE. This study will compare the safety and effectiveness of AD monotherapy versus MS monotherapy in treating people with BP II major depression.

Participation in this double-blind study will last up to 9 months. After screening, which includes a medical and psychiatric history review, a physical exam, an electrocardiogram (EKG) test, clinical laboratory tests, a urine-based drug test, and a pregnancy test if applicable, participants will be randomly placed into one of two treatment groups. Participants in the AD monotherapy group will be treated with venlafaxine, and participants in the MS monotherapy group will be treated with lithium. During the first 12 weeks, there will be a total of nine study visits lasting between 45 and 60 minutes. In these visits, participants will receive their study drug and will undergo various assessments, including a review of medication history and side effects, vital sign measurements, and questionnaires about depression and daily functioning. Blood samples will be taken at most visits.

Participants who respond well during the initial 12 weeks of therapy with either drug will have the option to continue treatment for 6 additional months. During this time, participants will continue their assigned treatment and will attend five monthly study visits that will repeat previous assessments and procedures.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00044616

Being tested
Venlafaxine, Lithium Carbonate
Keywords
Bipolar Type II Disorder, Hypomania, Antidepressant, Mood Stabilizer, Venlafaxine, Lithium Carbonate, Major Depressive Episode, Hypomanic Episodes, Prevention of Depression Relapse
Medical subject headings
Bipolar Disorder, Depression, Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenlafaxineDrug

    75 to 375 mg

  • Lithium CarbonateDrug

    300 to 2400 mg

Study groups in NCT00602537
Study groupRoleWhat they receive
IExperimentalAntidepressant therapy
Receives: Drug: Venlafaxine
IIActive comparatorMood stabilizer therapy
Receives: Drug: Lithium Carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressive Relapse

    These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered "depressive relapse" if relapsed by any of these times.

    Measured: Weeks 16, 20, 24, 30, 36

Secondary outcomes (1)

  1. Treatment-Emergent Mood Symptoms

    These subjects must be responders.

    Measured: Measured at Weeks 12 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00602537
Sponsor's protocol ID
R01MH060353-02
Other IDs
R01MH060353-02, 2R01MH060353-06A2
Status last verified
Apr 2017
First submitted
15 Jan 2008
Last updated
25 Apr 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lorenzo-Luaces L, Amsterdam JD, DeRubeis RJ. Residual anxiety may be associated with depressive relapse during continuation therapy of bipolar II depression. J Affect Disord. 2018 Feb;227:379-383. doi: 10.1016/j.jad.2017.11.028. Epub 2017 Nov 8.

    PubMed 29149756

  • Lorenzo-Luaces L, Amsterdam JD. Effects of venlafaxine versus lithium monotherapy on quality of life in bipolar II major depressive disorder: Findings from a double-blind randomized controlled trial. Psychiatry Res. 2018 Jan;259:455-459. doi: 10.1016/j.psychres.2017.11.025. Epub 2017 Nov 8.

    PubMed 29136600

  • Amsterdam JD, Lorenzo-Luaces L, DeRubeis RJ. Comparison of treatment outcome using two definitions of rapid cycling in subjects with bipolar II disorder. Bipolar Disord. 2017 Feb;19(1):6-12. doi: 10.1111/bdi.12462. Epub 2017 Feb 3.

    PubMed 28160351

  • Amsterdam JD, Lorenzo-Luaces L, DeRubeis RJ. Step-wise loss of antidepressant effectiveness with repeated antidepressant trials in bipolar II depression. Bipolar Disord. 2016 Nov;18(7):563-570. doi: 10.1111/bdi.12442. Epub 2016 Nov 2.

    PubMed 27805299

  • Amsterdam JD, Lorenzo-Luaces L, Soeller I, Li SQ, Mao JJ, DeRubeis RJ. Short-term venlafaxine v. lithium monotherapy for bipolar type II major depressive episodes: effectiveness and mood conversion rate. Br J Psychiatry. 2016 Apr;208(4):359-65. doi: 10.1192/bjp.bp.115.169375. Epub 2016 Feb 18.

    PubMed 26892848

  • Lorenzo-Luaces L, Amsterdam JD, Soeller I, DeRubeis RJ. Rapid versus non-rapid cycling bipolar II depression: response to venlafaxine and lithium and hypomanic risk. Acta Psychiatr Scand. 2016 Jun;133(6):459-69. doi: 10.1111/acps.12557. Epub 2016 Jan 24.

    PubMed 26803764

  • Amsterdam JD, Lorenzo-Luaces L, Soeller I, Li SQ, Mao JJ, DeRubeis RJ. Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study. J Affect Disord. 2015 Oct 1;185:31-7. doi: 10.1016/j.jad.2015.05.070. Epub 2015 Jun 26.

    PubMed 26143402

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Venlafaxine and Lithium Carbonate in people with Bipolar Disorder and Depression, run by University of Pennsylvania 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 15 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 25 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Depressive Relapse (time frame: Weeks 16, 20, 24, 30, 36). 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 NCT00602537, which also lists 7 linked publications.

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 25 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in