AzTrials
AzTrials

SchizophreniaPhase 2NCT00490516

ACP-104 in Acutely Psychotic Subjects With Schizophrenia

A Phase 2 study testing ACP-104 in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 21 sites 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 is a randomized, double-blind, placebo-controlled parallel-group, 6-week study, evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia who are experiencing an acute psychotic episode. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
ACP-104
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
247 participants
Where
21 sitesUnited States
Study dates
Jun 2007to Feb 2008
Phase
Phase 2
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female; 18-60 years of age
  • The subject is physically healthy and medically stable.
  • The subject is able to provide informed consent
  • The subject has been diagnosed with schizophrenia for at least 1 year
  • Currently experiencing an acute episode of psychosis
  • The subject is willing to comply with all study-related events including in-patient hospitalization for at least 3 weeks.
  • The subject has a caregiver who is willing and able to support the subject to ensure compliance with treatment and outpatient visits.
  • If the subject is female, subject must be of non-childbearing potential - OR- if she is capable of becoming pregnant, agrees to commit to use one of the approved methods of contraception, as defined by the protocol.

Who cannot join

  • If the subject is a pregnant or lactating (breast-feeding) female.
  • The subject has a significant risk of suicide, homicide, and/or harm to self or others.
  • Subject's psychotic symptoms have not improved with a therapeutic dose of antipsychotic treatment over the last 2 years.
  • The subject is experiencing his/her first episode of schizophrenia.
  • The subject has another psychotic disorder or has a history of autistic disorder or other pervasive developmental disorder (for example, mental retardation).
  • The subject has been prescribed or exposed to clozapine before.
Show all 9Show fewer
  • The subject has donated blood or plasma within 56 days prior to the Screening Visit.
  • The subject has participated in any clinical study within 30 days prior to the Screening Visit.
  • In addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Study site

    Anaheim, California, 92805

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Austin, Texas, 78754

  • Study site

    Baltimore, Maryland, 21202

  • Study site

    Bradenton, Florida, 34208

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Covina, California, 91724

  • Study site

    Culver City, California, 90232

  • Study site

    Garden Grove, California, 92845

  • Study site

    Glendale, California, 91206

  • Study site

    Huntington Beach, California, 92647

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Oceanside, California, 92056

  • Study site

    Paramount, California, 90723

  • Study site

    Pasadena, California, 91107

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Riverside, California, 92506

  • Study site

    San Diego, California, 92108

  • Study site

    St Louis, Missouri, 63118

  • Study site

    Willingboro, New Jersey, 08046

Other trials in United States

About this study

Official title: A Six-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase II Study of the Efficacy and Safety of ACP-104 in Acutely Psychotic Subjects With Schizophrenia

This is a randomized, double-blind, placebo-controlled parallel-group, 6-week study, evaluating two dose levels of ACP-104 or Placebo twice a day in patients with schizophrenia who are experiencing an acute psychotic episode.

Conditions
Schizophrenia
Being tested
ACP-104, Placebo
Keywords
Schizophrenia, psychotic disorders
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

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

  • ACP-104Drug

    200 mg, tablet, BID, 6 weeks

  • ACP-104Drug

    100 mg, tablet, BID, 6 weeks

  • PlaceboDrug

    placebo, tablet BID, 6 weeks

Study groups in NCT00490516
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: ACP-104
2ExperimentalNot described
Receives: Drug: ACP-104
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. PANSS

    Measured: 6 weeks

Timeline

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

  1. First posted22 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490516
Sponsor's protocol ID
ACP-104-003
Status last verified
Jan 2025
First submitted
21 Jun 2007
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACP-104 in people with Schizophrenia, run by ACADIA Pharmaceuticals Inc. at 21 sites 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 8 inclusion and 9 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 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

PANSS (time frame: 6 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 NCT00490516.

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 20 Jan 2025.

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