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Bipolar DisorderPhase 3NCT00183443

Treatment of Mania Symptoms With Drug Therapy

A Phase 3 study testing Divalproex-extended release (DVP-ER), Lithium and Quetiapine in people with Bipolar Disorder and Schizophrenia, run by Palo Alto Veterans Institute for Research 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
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Trial summary

This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder, Schizophrenia
What is being tested?
Divalproex-extended release (DVP-ER), Lithium and Quetiapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteUnited States
Study dates
Feb 2005to Nov 2010
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of bipolar I disorder or schizophrenia
  • Experiencing symptoms of mania at study entry
  • Able to speak and understand English
  • Willing and able to comply with all study requirements

Who cannot join

  • History of partial response or nonresponse to any of the drugs or drug combinations given in this study
  • History of intolerance to DVP, DVP-ER, lithium, or quetiapine
  • Disorders that would contraindicate the use of DV, DV-ER, lithium, or quetiapine
  • Use of antidepressants within 1 month prior to study entry
  • Use of fluoxetine within 3 months prior to study entry
  • Impaired cardiac function, as evidenced by abnormal EKG in participants 50 or over
Show all 10Show fewer
  • Unstable medical illness within 2 months prior to study entry
  • At risk for suicide
  • Substance abuse or dependence within 1 month prior to study entry
  • Pregnancy, breastfeeding, or plans to become pregnant during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania

This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.

Read the detailed description

Mania is a serious condition characterized by extreme excitement, mental and physical hyperactivity, insomnia, and disconnected thoughts. Symptoms of mania are common in patients with schizophrenia or bipolar disorder. When associated with these conditions, mania reaches psychotic proportions and often includes hallucinations, paranoia, and feelings of omnipotence. Such symptoms may put individuals with mania and those around them at risk for physical harm. Drug therapies that can safely and effectively treat symptoms of mania are needed. This study will compare three drug combinations in their ability to treat symptoms of mania in people with schizophrenia or bipolar I disorder.

This study will comprise a 12-week acute phase and a 14-week continuation phase. While the acute phase is the primary component of this study, the continuation phase will provide extended data on the characteristics and course of responders to the initial treatment combinations. Results from the continuation phase will be reported elsewhere. In the acute phase, participants will be randomly assigned to receive one of three treatments: divalproex-extended release (DV-ER) and lithium, DV-ER and quetiapine, or DV-ER and placebo. Participants will receive their intervention for 12 weeks. Participants will have weekly study visits for the first 4 weeks of the acute phase; biweekly study visits will occur for the following 8 weeks. After the acute phase, participants who have not responded to their drug regimen will complete their participation in the study.

Participants whose symptoms of mania have decreased will be offered enrollment in the 14-week continuation phase, during which time participants will continue the drug regimen they began in the acute phase. Participants will have biweekly study visits in the continuation phase. During each study visit in both phases, participants will be interviewed about their mania symptoms. Mania, depression, quality of life, and overall functioning scales will assess participants at study entry, at the end of the acute phase, and at the end of the continuation phase. Participants over 50 years of age will have an electrocardiogram (EKG) at study entry to determine cardiac function.

Being tested
Divalproex-extended release (DVP-ER), Lithium, Quetiapine
Keywords
Mania, Manic-depressive, Psychotic disorder
Medical subject headings
Bipolar Disorder, Schizophrenia, Mania, Psychotic Disorders

What participants receive

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

  • Divalproex-extended release (DVP-ER)Drug

    Also called depakote ER

    Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.

  • LithiumDrug

    Also called Lithobid

    Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.

  • QuetiapineDrug

    Also called Seroquel

    Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.

Study groups in NCT00183443
Study groupRoleWhat they receive
DVP + placeboPlacebo comparatorParticipants will receive divalproex ER at a therapeutic dose, plus placebo
Receives: Drug: Divalproex-extended release (DVP-ER)
DVP + QuetiapineActive comparatorParticipants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Receives: Drug: Divalproex-extended release (DVP-ER); Drug: Quetiapine
DVP + LithiumActive comparatorParticipants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Receives: Drug: Divalproex-extended release (DVP-ER); Drug: Lithium

What is being measured

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

  1. Symptoms of Mania, as Measured by Young Mania Rating Scale

    Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms.

    Measured: Week 12

Secondary outcomes (4)

  1. Hamilton Rating Scale for Depression (HAM-D,17)

    The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The 17-item Likert-type scale (range 0-50) includes eight questions with a 5-point scale (ranging from 0=not present to 4=severe) and nine items scored from 0 to 2. Higher scores indicate increased depression severity. The total sum of these 17 answers is used to arrive at the final score: normal (0-7), mild (8-13), moderate (14-18), severe (19-22), or very severe (>=23).

    Measured: Week 12

  2. Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)

    The Clinical Global Impression (CGI) rating scale was modified by Spearing and colleagues (1997) for use in bipolar disorder. CGI scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The revised CGI-Bipolar Version (CGI-BP) is effective in rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. The CGI-BP is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal, not ill) to 7 (very severely ill). Each component of the CGI is rated separately; the instrument does not yield a global score. Only severity of illness scores are reported. Increased scores represent increased illness severity

    Measured: Week 12

  3. Global Assessment of Functioning

    The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).

    Measured: Week 12

  4. Social and Occupational Functioning Assessment Scale (SOFAS)

    The Social and Occupational Functioning Assessment Scale (SOFAS) provides a rating of global social and occupational function independent of clinical symptoms. SOFAS is provided in the Diagnostic and Statistical Manual (DSM-IV) as an Axis V measure. The SOFAS is a global rating of current functioning, which is scored positively on a scale from 0 to 100. Higher scores represent higher levels of functioning. This instrument is a one-item rating of consumer functioning.

    Measured: Week 12

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionNov 2010
  4. Study completionNov 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183443
Sponsor's protocol ID
SUP0001AGG/ADO
Other IDs
R01MH069801, DSIR 83-ATSO
Status last verified
Jun 2018
First submitted
13 Sep 2005
Last updated
17 Jul 2018
Data monitoring committee
Yes

Publications

  • Cosgrove VE, Allende S, Gwizdowski I, Grace Fischer E, Ostacher M, Suppes T. A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder. Int J Bipolar Disord. 2022 Mar 2;10(1):7. doi: 10.1186/s40345-022-00252-w.

    PubMed 35235061

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Divalproex-extended release (DVP-ER), Lithium and Quetiapine in people with Bipolar Disorder and Schizophrenia, run by Palo Alto Veterans Institute for Research 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 4 inclusion and 10 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 17 Jul 2018. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Jul 2018). 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?

Symptoms of Mania, as Measured by Young Mania Rating Scale (time frame: Week 12). 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 NCT00183443, 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 17 Jul 2018.

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