deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00125931

Effects of Pentazocine on Manic Symptoms

Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms

Sponsor: Mclean Hospital

Interventions Talwin Nx
Updated 9 times since 2017 Last updated: Aug 25, 2014 Started: Sep 30, 2005 Primary completion: Aug 31, 2008 Completion: Dec 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Bipolar Disorder and is currently completed. Mclean Hospital leads this study, which shows 9 recorded versions since 2005 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Study Description(click to expand)

Opiates have a long history of treating mood disorders. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. The clinical use of opiate medications has been limited by their abuse/dependence potential. Studies of opiate receptor subtypes have raised the possibility that medications targeting the kappa/dynorphin system could be used to target mood symptoms with reduced/limited addiction potential. Rodent studies at Mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects. In addition, antimanic/antipsychotic medications regulate the activity of dynorphin cells. This study is a pilot open-label investigation using Talwin, a combination of pentazocine and naloxone. Pentazocine is a kappa agonist and mixed mu agonist. Two doses of Talwin will be given to acutely manic inpatients in a cumulative-dosing strategy. Measurements of manic symptoms will be conducted before, during, and after administration. This study will determine whether pentazocine has an immediate or sustained impact on acute mania symptoms.

Opiates have a long history of treating mood disorders. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. The clinical use of opiate medications has been limited by their abuse/dependence potential. Studies of opiate receptor subtypes have raised the possibility that medications targeting the kappa/dynorphin system could be used to target mood symptoms with reduced/limited addiction potential. Rodent studies at Mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects. In addition, antimanic/antipsychotic medications regulate the activity of dynorphin cells. This study is a pilot open-label investigation using Talwin, a combination of pentazocine and naloxone. Pentazocine is a kappa agonist and mixed mu agonist. Two doses of Talwin will be given to acutely manic inpatients in a cumulative-dosing strategy. Measurements of manic symptoms will be conducted before, during, and after administration. This study will determine whether pentazocine has an immediate or sustained impact on acute mania symptoms.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

  5. Dec 2021 — Dec 2022 [monthly]

    Completed PHASE2

Show 4 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Sep 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mclean Hospital
  • Stanley Medical Research Institute
Data source: Mclean Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.